Quality Management Systems
Quality Risk Management
Product And Process Development
Chemistry/ Manufacturing/ Controls (CMC)
Tech Transfer, Scale Up, Trouble-shooting
Acquisition/Partnering Due Diligence
Commissioning & Qualification
Analytical Methods and Validation
Clinical & Regulatory Affairs
Regulatory Strategy / Pre-submission Agency Communication
Clinical Evaluations and Reports
Regulatory Applications and Submissions
Additional Clinical & Regulatory Services
Richard Aleman of Pharmatech Associates shares some career advice in a profile published in Controlled Environments magazine. Aleman is VP of Regulatory Compliance for the Bay Area life sciences consultancy. He has 28 years of FDA experience in both the field and headquarters organizations, specializing in biopharmaceuticals, drugs and medical devices, including serving as the Biologics Specialist at the FDA’s Miami Resident Post.
Visit Pharmatech Associates at the ISPE/FDA/PQRI Quality Manufacturing Conference, June 6-7 in Bethesda, MD at the Bethesda North Marriott, booth #7.
Michele Levenson will be speaking on Cleaning Validation and Continued Process Verification at the Cleaning Validation Summit on May 23, 2016 in Philadelphia.
Bikash Chatterjee, President & CSO, will be the keynote speaker at PSG’s 44th Annual Pharmaceutical Symposium & Exhibition on May 10th. He will be presenting “The Promise and Challenges of Next Generation Gene Sequencing and Drug Therapy”.
Bikash Chatterjee, President & CSO, will present a case study on Data Integrity Challenges and Resolutions with a GMP Lab at the PDA of Southern California Data Integrity and Security Symposium on April 28 in Irvine, CA.
Visit Pharmatech Associates at the Outsourced Pharma Conference, April 20-21 in Boston, MA at the Westin Copley Place, Booth #14.
Visit Pharmatech Associates at the 25th Annual, San Francisco Chapter, ISPE Vendor Night and Exhibit on March 10, 2016 at AT&T Park
Visit Pharmatech Associates at MD&M West, The World’s Largest Medical Design & Manufacturing Event, in Anaheim on February 9-11.
Elly Earls of Pharma Technology Focus discusses the Drug Quality Security Act (DQSA), it’s requirements and challenges with Pharmatech’s President and Chief Science Officer, Bikash Chatterjee
Pharma Technology Focus
Visit Pharmatech Associates at the 2015 ISPE Annual Meeting, Nov 8-11, Philadephia, Pennsylvania. Bikash Chatterjee, President & CSO, Wai Wong, VP Validation, and Mark Mitchell, Principal Consultant presenting
Toll Free: 877.787.0177