What started in 1995 as a modest-sized business advising facility managers in validation expanded in both vision and scope as both the market and company matured. The addition of cornerstone colleagues Warren Baker and Bikash Chatterjee helped inspire the development of consulting solutions across the entire pharmaceutical product and medical device life cycle.
Grounded in scientific expertise, Pharmatech Associates has become one of the most innovative and respected companies serving the pharmaceutical and biotech industries. In 2021, Pharmatech Associates became the consulting arm of USP (US Pharmacopeia), a globally recognized leader in establishing drug quality standards for over 200 years, and serves clients throughout the world.
Pharmatech Associates has over 25 years of leadership in the life sciences industry. The company works with clients that range in size from start-ups to large multinationals. Beyond foundational strength in core US markets, Pharmatech has expanded service worldwide in lock-step with growing local demand for life sciences regulatory expertise. Our proven success managing international projects features a local “feet on the ground” approach. Each project is spearheaded by an internationally recognized staff of subject matter experts armed with necessary local regulatory insight to successfully commercialize products in virtually any jurisdiction around the world.
Our enduring mission is to serve as trusted advisors to scientists and engineers behind today’s newest innovations, helping bring novel therapies to patients who need them most.
Science represents the roots of our company. A grounding of scientific excellence is combined with decades of technical expertise to make us unique amongst international consultancies.
We make quality medicines and medical devices more accessible to patients. Our ability to see the interconnections between complex processes allows us to successfully commercialize products globally.
From innovation to execution, our approach provides a clear and proven roadmap to navigate complex development processes.
Our enduring mission is to serve as trusted advisors to scientists and engineers behind today’s newest innovations, helping bring novel therapies to patients who need them most.
Science represents the roots of our company. A grounding of scientific excellence is combined with decades of technical expertise to make us unique amongst international consultancies.
We make quality medicines and medical devices more accessible to patients. Our ability to see the interconnections between complex processes allows us to successfully commercialize products globally.
From innovation to execution, our approach provides a clear and proven roadmap to navigate complex development processes.
USP has a 200 year history of working with drug sponsors and regulators to develop and manufacture quality medicines. USP’s acquisition of Pharmatech Associates extends additional support to manufacturers as they navigate the complexities of regulatory, scientific, and business environments. Pharmatech Associates and USP share a common goal of helping manufacturers bring safe, quality medicines and treatments to patients who need them. Pharmatech Associates will complement, but operate independently from USPs regulatory standards organization.
We bring together the finest minds in life sciences to create strategies for next generation medicines and diagnostic tests for the global market.
A complex product development journey demands people who are up to the challenge.
Our teams draw on decades of experience to serve the complex needs of pharmaceutical manufacturers and regulated life science companies.
Chief Executive Officer
Ms Yadlapalli has worked in the bio-pharmaceutical industry for over 20 years and brings extensive global industry and regulatory expertise in small molecules, innovator drugs, generics, and biosimilars. Yadlapalli has held leadership positions in fortune 500 and international companies, in finance, business development, strategic marketing and regulatory affairs. Prior to Pharmatech, she served as Vice President, International Government and Regulatory Affairs at US Pharmacopeia (USP). As Regional Director of South Asia at USP, Yadlapalli worked extensively to support manufacturers to supply quality medicines to all major markets and held senior-level positions at Dr. Reddy’s Laboratories, Valeant Pharmaceuticals International, and Johnson & Johnson. She is a CHIEF member, a network of women executive leaders in the US, holds an MBA in Marketing and Entrepreneurship from the Indian School of Business, a B.A. in Economics from Rutgers University, and a B.B.M in Accounting from Bangalore University.
Chief Science Officer
Bikash Chatterjee has worked in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years, guiding the successful approval of a dozen new products within the U.S. and Europe. Chatterjee has developed and transferred products and processes to satellite operations and CMOs throughout his career, designing and implementing systems to satisfy the requirements for ICH Q8, Q9, and Q10, e-pedigree, risk-based validation, and developing a six sigma-based methodology to support the PAT initiative. He is an ISO 9000 certified lead assessor and six sigma / lean manufacturing master black belt. Chatterjee is a member of the USP national advisory board, past chairman of the Golden Gate Chapter of the American Society of Quality (ASQ. Chatterjee is a regular editorial contributor to several industry journals, serves on the editorial advisory board for Pharmaceutical Manufacturing and Pharmaceutical Technology, and is a founding member of the CPhl expert industry advisory board. Chatterjee is the author of "Applying Lean Six Sigma in the Pharmaceutical Industry” (ISBN: 978-0-566-09204-6). He holds a B.A. in biochemistry and a B.S. in chemical engineering from the University of California at San Diego.
Chief Financial Officer
Mr. Snyder is a proven leader with 25 years of experience in developing, implementing, and optimizing operational and financial processes. He has a successful track record in strategic executive leadership with small businesses that provide business services, consulting services, and technology services. Snyder uses a consultative approach, drawing on his diverse professional background working in many industries, for companies of varying size, and in different roles. Prior to joining Pharmatech Associates, he held executive leadership positions at TMA Direct and as an outsourced COO/CFO for various entities. Snyder also held consulting management positions at Cizer Software, INTIEX, and PricewaterhouseCoopers. He has consulted for the Executive Office of the President (EOP), Environmental Protection Agency (EPA), United States Postal Service (USPS), International Air Transport Association (IATA), Air Transport Association (ATA), and MCI Communications (MCI).
Managing Director
Stephanie Gaulding has over 25 years working with quality management systems and validation program management in the pharmaceutical, biotech, medical device, and related life science industries. She develops and delivers efficient and sustainable quality management systems assuring compliance with global regulatory requirements and industry best practices to help start-up and industry-leading clients pass regulatory inspections and achieve their desired results. Gaulding has held quality management leadership positions at Mediatech and Boehringer Ingelheim Chemicals. She is an ASQ certified quality auditor and ASQ certified pharmaceutical GMP professional. Gaulding is actively involved in PDA, ISPE, and ASQ through co-teaching ISPE’s “Applying Quality Risk Management” course, as a member leader in the ASQ Human Development and Leadership Division, participating in the certified pharmaceutical GMP professional exam development process, and serving on the PDA member newsletter editorial committee. She holds a M.Sc. in biotechnology from Johns Hopkins and a B.Sc. in biology from Virginia Tech.
Executive Director, Marketing & Sales
Janette Buechler has over 20 years of experience in marketing and event planning and manages our sales and marketing departments at Pharmatech. Buechler is a San Francisco Bay Area native, a member of the American Marketing Association, and an active member of ISPE. She studied business administration with a concentration in marketing at San Jose State University and is inspired by the challenge of building a company brand, the power of social media, and the importance of a professional network.
Head of Operations, Western US
Wai Wong has over 20 years of equipment, facility, and process validation experience in the pharmaceutical, medical device, and biologic industries, and has earned an international reputation for expertise navigating the complex requirements of the FDA, EU and PIC/s compliance. Prior to joining Pharmatech in August 2005, Wong was the West Coast regional validation manager for Fluor Enterprises, and a senior validation engineer at Nektar Therapeutics, formerly Inhale Therapeutic Systems. He began his biopharmaceutical industry career at Genentech as an aseptic filling technician and was promoted to a process engineer role responsible for introducing new equipment and processes into Genentech’s fill-finish operation for both clinical and commercial manufacturing. Wong has authored multiple articles relating to the biopharmaceutical and medical device industries. He is a six-sigma green belt has been involved in many FMEA exercises at numerous client sites. He holds a B.A. in molecular and cell biology with emphasis on biochemistry from the University of California at Berkeley.
Head of Operations, Eastern US
Drawing from a 30+-year career in quality and leadership roles across global companies in the pharmaceutical industry, Mike Porter has extensive GxP knowledge in the areas of medical devices, manufacturing, laboratory, and clinical trials. He has honed a collaborative approach to implement efficient, effective, and sustainable quality management system solutions that are compliant with global regulatory requirements and industry best practices— appropriate whether targeting commercial, start-up, or clinical operations. Porter has held leadership positions at Eli Lilly & Company, Myriad Genetics, and PPD (Pharmaceutical Product Development) in addition to his consulting experience. He is actively involved in ISPE through co-teaching ISPE’s “Applying Quality Risk Management” course and is a member of ASQ. He holds a M.Sc. biomedical engineering from Clemson University, and a B.Sc. engineering science and mechanics from Virginia Tech.
Head of PMO
Michele Levenson has over 20 years’ experience in the biopharmaceutical, pharmaceutical, and medical device/diagnostic industries, with an emphasis on process, equipment, utility, facility, computer, and automation validation and project and people management. Levenson’s areas of expertise include equipment/facility/utility/automation commissioning & qualification, quality management systems, statistical analyses, process design, and process validation. Her expertise spans solid dose manufacturing delivery systems to aseptic biotech processes and drug delivery systems. Throughout her career she has been involved with process and technology transfers, process optimization and redesign projects, and cell culture fermentation operations. Levenson is extensively involved in leading commissioning and qualification mission critical projects for gene therapy, pharmaceutical, and biotechnology companies. She is often engaged in remediation activities for pharmaceutical and biotechnology companies that are under regulatory action specifically for Process Validation in the U.S. and has been involved in the development of policies and procedures for process validation programs deployed around the world. Levenson is a lean / six sigma green belt and certified project management professional (PMP). She holds an executive MBA from Saint Mary’s College of California, and a B.S. degree in general life sciences with a minor in Spanish from Penn State University.
Pharmaceutical Continuous Manufacturing (PCM) Practice Lead
Lawrence De Belder has over 15 years of project management, equipment design, and validation experience in the pharmaceutical industry. Previously with Johnson and Johnson he designed and installed multiple filling and packaging lines including a detailed design and start of a $100MM+ continuous manufacturing project in Puerto Rico. De Belder was also responsible for oversight of all continuous manufacturing projects and activities of the Janssen Supply chain and initiated multiple collaborations with academics and other pharma companies. He started the ISPE working group on continuous manufacturing (CM), and chaired the CM and PAT working groups at the IQ consortium for several years with a focus on costs, benefits and requirements related to this novel technology. De Belder leads the continuous manufacturing consulting group at Pharmatech Associates. He speaks five languages fluently and holds a MSc degree from Group-T Belgium with an emphasis on Energy and automation.
Practice Lead
Peter Rafa serves as executive director of Project Design and Startup. His focus is to engage with Pharmatech clients to define project scope, roles and responsibilities, and expectations prior to contract award, ensuring that the Pharmatech team integrates within the project environment. Rafa began his career at Pharmatech in 2001 as a validation engineer. Since then, he has become a recognized leader in manufacturing facility startup and qualification, equipment qualification of solid dosage and aseptic processes, and computerized systems validation. Rafa has extensive experience in designing and implementing quality management systems (QMS) primarily in the startup environment for biologics, devices, and other new regulated therapeutic arenas. He is dedicated to providing high caliber, above and beyond service to Pharmatechs’ clients and is thrilled by the challenge of each individual opportunity. He holds a B.S. in chemical engineering from Johns Hopkins University.
Practice Lead
Dr. Lambert has over two decades of experience in the research, development, and analysis of pharmaceutical products, from pre-clinical phases through NDA/BLA submission. He has developed a wide range of novel and technically challenging pharmaceutical products—small-molecule and biologics—and held leadership roles in the pharmaceutical industry. Lambert’s key accomplishments include the development of pulmonary delivery of proteins and stabilization of monoclonal antibodies (ProMaxx® microsphere technology), and the first manufactured vaccine patch (E coli vaccine) for human trials (Phase I/II/III). He holds a Ph.D. in chemistry from the University of Akron in Ohio, and a B.S. in biochemistry from State University of New York College at Plattsburgh.
Founder
Calvin Wong has been active in the biotech, pharmaceutical, medical device, and food industries for more than 40 years, in operations, engineering, technical services, and validation management for many biotech and pharmaceutical companies, including Syntex Laboratories. Wong founded Pharmatech Validation Services in 1995 to work with the leading pharmaceutical and biotech clients in Asia and North America, providing basis of design and conceptual design development for GMP pharmaceutical and biotech manufacturing facilities, comprising commissioning, qualification and validation program development, project and protocol development, technology transfer, NDA submissions for drugs and combination products, regulatory compliance guidance, audits and remediation, QMS development, lean six sigma training, business strategy development and tactical deployment. He holds a B.A. in microbiology from the University of California at Berkeley, and lives with his wife in the San Francisco Bay Area.
Ms Yadlapalli has worked in the bio-pharmaceutical industry for over 20 years and brings extensive global industry and regulatory expertise in small molecules, innovator drugs, generics, and biosimilars. Yadlapalli has held leadership positions in fortune 500 and international companies, in finance, business development, strategic marketing and regulatory affairs. Prior to Pharmatech, she served as Vice President, International Government and Regulatory Affairs at US Pharmacopeia (USP). As Regional Director of South Asia at USP, Yadlapalli worked extensively to support manufacturers to supply quality medicines to all major markets and held senior-level positions at Dr. Reddy’s Laboratories, Valeant Pharmaceuticals International, and Johnson & Johnson. She is a CHIEF member, a network of women executive leaders in the US, holds an MBA in Marketing and Entrepreneurship from the Indian School of Business, a B.A. in Economics from Rutgers University, and a B.B.M in Accounting from Bangalore University.
Bikash Chatterjee has worked in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years, guiding the successful approval of a dozen new products within the U.S. and Europe. Chatterjee has developed and transferred products and processes to satellite operations and CMOs throughout his career, designing and implementing systems to satisfy the requirements for ICH Q8, Q9, and Q10, e-pedigree, risk-based validation, and developing a six sigma-based methodology to support the PAT initiative. He is an ISO 9000 certified lead assessor and six sigma / lean manufacturing master black belt. Chatterjee is a member of the USP national advisory board, past chairman of the Golden Gate Chapter of the American Society of Quality (ASQ. Chatterjee is a regular editorial contributor to several industry journals, serves on the editorial advisory board for Pharmaceutical Manufacturing and Pharmaceutical Technology, and is a founding member of the CPhl expert industry advisory board. Chatterjee is the author of "Applying Lean Six Sigma in the Pharmaceutical Industry” (ISBN: 978-0-566-09204-6). He holds a B.A. in biochemistry and a B.S. in chemical engineering from the University of California at San Diego.
Mr. Snyder is a proven leader with 25 years of experience in developing, implementing, and optimizing operational and financial processes. He has a successful track record in strategic executive leadership with small businesses that provide business services, consulting services, and technology services. Snyder uses a consultative approach, drawing on his diverse professional background working in many industries, for companies of varying size, and in different roles. Prior to joining Pharmatech Associates, he held executive leadership positions at TMA Direct and as an outsourced COO/CFO for various entities. Snyder also held consulting management positions at Cizer Software, INTIEX, and PricewaterhouseCoopers. He has consulted for the Executive Office of the President (EOP), Environmental Protection Agency (EPA), United States Postal Service (USPS), International Air Transport Association (IATA), Air Transport Association (ATA), and MCI Communications (MCI).
Stephanie Gaulding has over 25 years working with quality management systems and validation program management in the pharmaceutical, biotech, medical device, and related life science industries. She develops and delivers efficient and sustainable quality management systems assuring compliance with global regulatory requirements and industry best practices to help start-up and industry-leading clients pass regulatory inspections and achieve their desired results. Gaulding has held quality management leadership positions at Mediatech and Boehringer Ingelheim Chemicals. She is an ASQ certified quality auditor and ASQ certified pharmaceutical GMP professional. Gaulding is actively involved in PDA, ISPE, and ASQ through co-teaching ISPE’s “Applying Quality Risk Management” course, as a member leader in the ASQ Human Development and Leadership Division, participating in the certified pharmaceutical GMP professional exam development process, and serving on the PDA member newsletter editorial committee. She holds a M.Sc. in biotechnology from Johns Hopkins and a B.Sc. in biology from Virginia Tech.
Janette Buechler has over 20 years of experience in marketing and event planning and manages our sales and marketing departments at Pharmatech. Buechler is a San Francisco Bay Area native, a member of the American Marketing Association, and an active member of ISPE. She studied business administration with a concentration in marketing at San Jose State University and is inspired by the challenge of building a company brand, the power of social media, and the importance of a professional network.
Wai Wong has over 20 years of equipment, facility, and process validation experience in the pharmaceutical, medical device, and biologic industries, and has earned an international reputation for expertise navigating the complex requirements of the FDA, EU and PIC/s compliance. Prior to joining Pharmatech in August 2005, Wong was the West Coast regional validation manager for Fluor Enterprises, and a senior validation engineer at Nektar Therapeutics, formerly Inhale Therapeutic Systems. He began his biopharmaceutical industry career at Genentech as an aseptic filling technician and was promoted to a process engineer role responsible for introducing new equipment and processes into Genentech’s fill-finish operation for both clinical and commercial manufacturing. Wong has authored multiple articles relating to the biopharmaceutical and medical device industries. He is a six-sigma green belt has been involved in many FMEA exercises at numerous client sites. He holds a B.A. in molecular and cell biology with emphasis on biochemistry from the University of California at Berkeley.
Drawing from a 30+-year career in quality and leadership roles across global companies in the pharmaceutical industry, Mike Porter has extensive GxP knowledge in the areas of medical devices, manufacturing, laboratory, and clinical trials. He has honed a collaborative approach to implement efficient, effective, and sustainable quality management system solutions that are compliant with global regulatory requirements and industry best practices— appropriate whether targeting commercial, start-up, or clinical operations. Porter has held leadership positions at Eli Lilly & Company, Myriad Genetics, and PPD (Pharmaceutical Product Development) in addition to his consulting experience. He is actively involved in ISPE through co-teaching ISPE’s “Applying Quality Risk Management” course and is a member of ASQ. He holds a M.Sc. biomedical engineering from Clemson University, and a B.Sc. engineering science and mechanics from Virginia Tech.
Michele Levenson has over 20 years’ experience in the biopharmaceutical, pharmaceutical, and medical device/diagnostic industries, with an emphasis on process, equipment, utility, facility, computer, and automation validation and project and people management. Levenson’s areas of expertise include equipment/facility/utility/automation commissioning & qualification, quality management systems, statistical analyses, process design, and process validation. Her expertise spans solid dose manufacturing delivery systems to aseptic biotech processes and drug delivery systems. Throughout her career she has been involved with process and technology transfers, process optimization and redesign projects, and cell culture fermentation operations. Levenson is extensively involved in leading commissioning and qualification mission critical projects for gene therapy, pharmaceutical, and biotechnology companies. She is often engaged in remediation activities for pharmaceutical and biotechnology companies that are under regulatory action specifically for Process Validation in the U.S. and has been involved in the development of policies and procedures for process validation programs deployed around the world. Levenson is a lean / six sigma green belt and certified project management professional (PMP). She holds an executive MBA from Saint Mary’s College of California, and a B.S. degree in general life sciences with a minor in Spanish from Penn State University.
Lawrence De Belder has over 15 years of project management, equipment design, and validation experience in the pharmaceutical industry. Previously with Johnson and Johnson he designed and installed multiple filling and packaging lines including a detailed design and start of a $100MM+ continuous manufacturing project in Puerto Rico. De Belder was also responsible for oversight of all continuous manufacturing projects and activities of the Janssen Supply chain and initiated multiple collaborations with academics and other pharma companies. He started the ISPE working group on continuous manufacturing (CM), and chaired the CM and PAT working groups at the IQ consortium for several years with a focus on costs, benefits and requirements related to this novel technology. De Belder leads the continuous manufacturing consulting group at Pharmatech Associates. He speaks five languages fluently and holds a MSc degree from Group-T Belgium with an emphasis on Energy and automation.
Peter Rafa serves as executive director of Project Design and Startup. His focus is to engage with Pharmatech clients to define project scope, roles and responsibilities, and expectations prior to contract award, ensuring that the Pharmatech team integrates within the project environment. Rafa began his career at Pharmatech in 2001 as a validation engineer. Since then, he has become a recognized leader in manufacturing facility startup and qualification, equipment qualification of solid dosage and aseptic processes, and computerized systems validation. Rafa has extensive experience in designing and implementing quality management systems (QMS) primarily in the startup environment for biologics, devices, and other new regulated therapeutic arenas. He is dedicated to providing high caliber, above and beyond service to Pharmatechs’ clients and is thrilled by the challenge of each individual opportunity. He holds a B.S. in chemical engineering from Johns Hopkins University.
Dr. Lambert has over two decades of experience in the research, development, and analysis of pharmaceutical products, from pre-clinical phases through NDA/BLA submission. He has developed a wide range of novel and technically challenging pharmaceutical products—small-molecule and biologics—and held leadership roles in the pharmaceutical industry. Lambert’s key accomplishments include the development of pulmonary delivery of proteins and stabilization of monoclonal antibodies (ProMaxx® microsphere technology), and the first manufactured vaccine patch (E coli vaccine) for human trials (Phase I/II/III). He holds a Ph.D. in chemistry from the University of Akron in Ohio, and a B.S. in biochemistry from State University of New York College at Plattsburgh.
Calvin Wong has been active in the biotech, pharmaceutical, medical device, and food industries for more than 40 years, in operations, engineering, technical services, and validation management for many biotech and pharmaceutical companies, including Syntex Laboratories. Wong founded Pharmatech Validation Services in 1995 to work with the leading pharmaceutical and biotech clients in Asia and North America, providing basis of design and conceptual design development for GMP pharmaceutical and biotech manufacturing facilities, comprising commissioning, qualification and validation program development, project and protocol development, technology transfer, NDA submissions for drugs and combination products, regulatory compliance guidance, audits and remediation, QMS development, lean six sigma training, business strategy development and tactical deployment. He holds a B.A. in microbiology from the University of California at Berkeley, and lives with his wife in the San Francisco Bay Area.
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
1.877.787.0177
510.732.0177
22320 Foothill Blvd. Suite 330, Hayward CA 94541
