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 and 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
Visit Pharmatech Associates at 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, Crystal Gateway Marriott, June 5-6.
Mark Mitchell will be presenting a case study at the Process Validation Summit 2017 entitled, “Process Control Strategy and Process Performance Qualification of a Drug/Device Combination Product on May 18th in Philadelphia.
Visit Pharmatech Associates at MD&M West 2017 Show, Feb 7-9, Anaheim Convention Center.
Visit Pharmatech Associates at the 2016 ISPE Annual Meeting, Sept 18-21, Marriott Marquis, Atlanta, GA.
Visit Pharmatech Associates at the Outsourced Pharma Event on Aug 22-24 in La Jolla, CA at the Hyatt Regency, Booth #36.
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.
Toll Free: 877.787.0177