For over thirty years Pharmatech has helped manufacturers turn complex ideas into reliable supply of medicines. We began in the mid nineteen nineties as a small group of engineers and scientists focused on validation and facility projects in the San Francisco Bay Area. As the industry evolved, we grew with it, moving from single site problem solving to end to end support across the product life cycle. Over the decades our teams have worked on small molecules, biologics, vaccines, cell and gene therapies and combination products. The work has ranged from remediation and inspection readiness through greenfield facility design, continuous manufacturing, quality systems and CMC strategy for global filings. Each project added to a practical playbook that now supports clients at every stage of development and commercial supply. What has not changed is how we show up. We stay close to the plant floor and the project room, translate regulations into workable plans and keep patients at the center of every decision. Today, as a United States Pharmacopeia company, Pharmatech Associates combines three decades of hands on experience with the strength of a global standards organization to help you build confident, compliant and resilient manufacturing for the long term.
Grounded in scientific expertise and real world experience, Pharmatech has grown into a trusted partner for pharmaceutical, biotech and medical device companies that need support across CMC, quality, regulatory, compliance and manufacturing. Our teams bring together people who have sat in your seat in development, operations and regulatory roles and who understand how decisions made today play out in the plant tomorrow. In 2021, Pharmatech Associates became the consulting arm of United States Pharmacopeia. USP is a globally recognized organization that has established drug quality standards for more than two hundred years. As part of USP, we combine hands on consulting with the strength of a global standards setter and now serve clients throughout the world who are working to build safer, more resilient supply of medicines.
For 30 years Pharmatech Associates has supported life science companies at every stage of growth, from early-stage startups to global multinationals. While our roots are in the United States, our work now spans North America, Europe, Asia and Latin America in step with the globalization of development and manufacturing. On each project we bring subject matter experts who understand both global expectations and local regulatory practice. We combine product, process and regional insight with a strong onsite presence when it is needed. This allows us to work effectively with health authorities and partners and to help clients move products toward commercialization in a wide range of jurisdictions.
Our team brings together scientists, engineers and business leaders who have spent their careers in development, manufacturing and quality. We understand the pressures you face and work with you to find practical ways forward.
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 Operating 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).
Executive Vice President
Claudia Lin is a biotech veteran with over 30 years of experience in multi-national companies and startups in the U.S., EU and China working in life cycle biologics product development, manufacturing, and quality. A global supply chain expert, Claudia’s work focuses on phase-appropriate product development, quality management, and regulatory compliance for all biologics. She holds a PhD in cell and molecular biology from the University of California, Berkeley.
Executive Consultant & Head of PMO
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.
Head of Sales & Practice Lead (PCM)
Richard Steiner, a seasoned professional with over 30 years of experience in sales, currently leads the Pharmaceutical Continuous Manufacturing focus area and is the Head of Sales for Pharmatech Associates. Richard's extensive career includes notable leadership roles, such as heading the Leistritz business unit in Pharma Extrusion before joining GEA in 2012. At GEA Pharma Systems, he excelled as the Global Sales Director for Continuous Processing Technologies. A distinguished expert in continuous manufacturing, Richard is a sought-after speaker at industry conferences and a frequent contributor to trade journals and scientific textbooks. His passion lies in advocating for the implementation of continuous processing in the pharmaceutical industry (PCM). Richard's wealth of knowledge is backed by a solid educational foundation, having attended the University of Applied Sciences in Nuernberg and the FU University of Berlin. He holds degrees in Mechanical Engineering (Dipl. Ing.), MBM, and MBA. With a proven track record of success and a commitment to advancing pharmaceutical continuous manufacturing, Richard Steiner continues to make significant contributions to the industry through his leadership, insights, and dedication.
Executive Consultant
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.
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.
Vice President, Head of Business Development & Marketing
Elizabeth “Beth” Akiwowo Hoffner is Vice President, Head of Business Development & Marketing. She has more than 20 years of experience in the pharmaceutical and life-sciences industry, spanning roles in R&D, CDMO/CRO services, and commercial leadership across small molecules, biologics, and advanced therapies. At Pharmatech, she leads the business development and marketing teams, builds partnerships with pharma and biotech companies, and helps clients navigate CMC and regulatory complexity so they can bring quality medicines to patients more efficiently.
Assistant Controller
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).
Claudia Lin is a biotech veteran with over 30 years of experience in multi-national companies and startups in the U.S., EU and China working in life cycle biologics product development, manufacturing, and quality. A global supply chain expert, Claudia’s work focuses on phase-appropriate product development, quality management, and regulatory compliance for all biologics. She holds a PhD in cell and molecular biology from the University of California, Berkeley.
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.
Richard Steiner, a seasoned professional with over 30 years of experience in sales, currently leads the Pharmaceutical Continuous Manufacturing focus area and is the Head of Sales for Pharmatech Associates. Richard's extensive career includes notable leadership roles, such as heading the Leistritz business unit in Pharma Extrusion before joining GEA in 2012. At GEA Pharma Systems, he excelled as the Global Sales Director for Continuous Processing Technologies. A distinguished expert in continuous manufacturing, Richard is a sought-after speaker at industry conferences and a frequent contributor to trade journals and scientific textbooks. His passion lies in advocating for the implementation of continuous processing in the pharmaceutical industry (PCM). Richard's wealth of knowledge is backed by a solid educational foundation, having attended the University of Applied Sciences in Nuernberg and the FU University of Berlin. He holds degrees in Mechanical Engineering (Dipl. Ing.), MBM, and MBA. With a proven track record of success and a commitment to advancing pharmaceutical continuous manufacturing, Richard Steiner continues to make significant contributions to the industry through his leadership, insights, and dedication.
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.
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.
Elizabeth “Beth” Akiwowo Hoffner is Vice President, Head of Business Development & Marketing. She has more than 20 years of experience in the pharmaceutical and life-sciences industry, spanning roles in R&D, CDMO/CRO services, and commercial leadership across small molecules, biologics, and advanced therapies. At Pharmatech, she leads the business development and marketing teams, builds partnerships with pharma and biotech companies, and helps clients navigate CMC and regulatory complexity so they can bring quality medicines to patients more efficiently.
United States Pharmacopeia has a 200 year history of working with drug sponsors, manufacturers and regulators to improve the quality of medicines. USP sets public standards that support safe, effective and consistent therapies around the world.
Through Pharmatech Associates, manufacturers gain practical support as they navigate complex regulatory, scientific and business environments. We help clients apply standards, design control strategies, plan facilities and quality systems and prepare for inspections.
Pharmatech and USP share a single goal to help manufacturers bring safe, high quality medicines and treatments to the patients who need them. Pharmatech complements USP’s standards setting work, while operating as an independent consulting organization.
Our teams bring experienced scientists, engineers, quality and regulatory specialists together to create practical strategies for next generation medicines and diagnostic tests for the global market.
We measure our success by the impact on patients. When choices are close, we favor what improves product quality, reliability and safety.
We give clear and realistic guidance, even when it means hard conversations about risk, cost or timelines. You always know where you stand.
We connect strong science with real operations. Our recommendations are grounded in data and experience and are designed to work in the plant and in front of regulators.
We work as part of your team, build capability and leave your organization stronger than when we arrived.
We measure our success by the impact on patients. When choices are close, we favor what improves product quality, reliability and safety.
We give clear and realistic guidance, even when it means hard conversations about risk, cost or timelines. You always know where you stand.
We connect strong science with real operations. Our recommendations are grounded in data and experience and are designed to work in the plant and in front of regulators.
We work as part of your team, build capability and leave your organization stronger than when we arrived.
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
Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583
