Pharmatech Associates, a global consultancy for the life science industry, advises U.S. and global drug sponsors and manufacturers of quality medicines in many major markets. A wholly owned subsidiary of U.S. Pharmacopeia (USP) with expertise in small molecule, cell & gene therapy, biologics –monoclonal antibodies– and advanced manufacturing technologies. Services include product and process development, quality management, quality assurance, and product management. Pharmatech Associates helps clients navigate the regulatory landscape of the FDA and international health authorities and provides guidance for U.S. market entry. Pharmatech Associates serves clients ranging from start-ups to large multi-national corporations. The company’s multidisciplinary team of professionals are thought leaders with integrated knowledge across all areas of product development who bring industry experience to every engagement reducing time-to-market for their clients. One of Pharmatech Associates’ core strengths lies in strategic program development. Pharmatech’s team assists clients in navigating the regulatory landscape of FDA and international health authorities, helping them achieve and maintain compliance. This expertise is vital to success during product development, manufacturing, and commercialization phases, ensuring that clients meet stringent regulatory requirements while meeting business objectives and anticipating FDAs downstream requirements to reduce program risk. Pharmatech Associates guides clients by helping organizations implement robust quality management systems, conduct risk assessments, investigate deviations through thorough root cause analysis, determine CAPAs, and provide training to build competency and ensure compliance with industry standards.
External link for Pharmatech Associates, a USP company
22320 Foothill Blvd.
Suite 330
Hayward, California 94541, US
ISPE Women in Pharma is growing and welcoming more members every year. Thank you AstraZeneca for making this event possible!
ISPE Women in Pharma hosted a unique event to highlight the importance of diversity. It was an unforgettable Masquerade Networking event. June Page from FDA showed up! Thank you to the event sponsor AstraZeneca. #pharmaceuticalmanufacturing #inclusiveworkplace #ispeam24
Join us in welcoming Claudia Lin to our team! Claudia is a global supply chain expert, her work focuses on phase-appropriate product development, quality management, and regulatory compliance for all biologics.
Join us at the next Outsourced Pharma Live for an exploration of critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies. Registration is free.
Free virtual event next week on Oct. 10! Selecting & Managing #CDMOs for Novel Therapies Speakers are: -John Aikens, Pharmatech Associates, a USP company -Scott Jeffers Ph.D., GenSight Biologics -Vaibhav Patel, University of Minnesota Moderated by Louis Garguilo, Chief Editor of Outsourced Pharma. Register for free here: https://lnkd.in/ePMjguKd #contractmanufacturing #outsourcing #drugmanufacturing
Join the Pharmatech Associates team next week at CPHI Worldwide in Milan, Italy from Oct. 8 – 10! Find us at USP’s Booth 4C113 or set up time to meet about your next project here: contact@pai-qbd.com
Are you attending CPHI Milan October 8 - 10? If so, let’s talk about drug development, quality, and the complexities of regulatory filings! Visit us at USP’s Booth 4C113 or connect with us here to set time to meet with the Pharmatech team: contact@pai-qbd.com
💡 Webinar: Overcoming Challenges in PCM for Drug Substance 💡 Join us for tomorrow’s free webinar at 11:00 AM EDT, exploring the recognized hurdles and implementation challenges of PCM for Drug Substance. Learn how to navigate these challenges effectively. What you’ll gain: ✅ Understanding of PCM principles for Drug Substance ✅ Knowledge of available unit operations and selection criteria ✅ Insights into current PCM DS products and publications ✅ Strategies for overcoming implementation hurdles ✅ Analysis of the business case for PCM DS adoption Register here now: https://hubs.ly/Q02QlqCh0 #PCM #DrugSubstance #ContinuousManufacturing
Join Tomorrow’s Webinar: Entering the U.S. Market: What Does it Take? Are you ready to expand your pharmaceutical or biologic drug offerings into the largest commercial market in the world? Join us tomorrow morning at 11:00 AM EDT for an exclusive webinar. You’ll learn: ✅ Essential steps for U.S. FDA filings ✅ Which products to pursue ✅ How to ensure quality management maturity ✅ Requirements for achieving commercial readiness Register now and secure your spot: https://hubs.ly/Q02Qlhsk0 #DrugDevelopment #QualityManagement #RegulatoryAffairs
🌟 Join Us for a Comprehensive Webinar on PCM(Pharmaceutical Continuous Manufacturing) for Drug Substance 🌟 We’re excited to host a webinar on September 26th, 2024, at 11:00 AM EDT focusing on PCM for Drug Substance manufacturing. Discover the current landscape, challenges, and business cases for PCM DS. In this webinar, you'll learn: 🔹 The fundamentals and definitions of PCM for Drug Substance 🔹 Available technologies and their applications in PCM DS 🔹 Current trends and commercial applications of PCM DS 🔹 Challenges in implementation and risk management 🔹 Developing a strong business case for PCM DS Sign up now: https://hubs.ly/Q02Qlg-x0 #DrugSubstance #PharmaWebinar #ContinuousManufacturing
Free Webinar: Entering the U.S. Market: What Does it Take? Join us on September 25th, 2024, at 11:00 AM EDT to learn how to bring your biosimilar, generic, and complex generic drugs into the U.S. market. Gain insights from industry experts on navigating the regulatory landscape and ensuring commercial readiness. Topics include: 🌟 Portfolio Analysis 🌟 Quality Management Maturity (QMM) 🌟 Regulatory Submission Processes 🌟 Commercial Readiness Strategies Register now: https://hubs.ly/Q02QltLH0 #DrugDevelopment #RegulatoryCompliance #QualityAssurance
📢 Explore PCM for Drug Substance with Us! 📢 Join our free webinar on September 26th, 2024, at 11:00 AM EDT. We’ll discuss the current landscape of PCM technology for drug substance manufacturing. Key topics we’ll cover: ✅Introduction to Pharmaceutical Continuous Manufacturing (PCM) ✅Review of available technologies and equipment for PCM DS ✅Insights into the current PCM DS landscape, including commercial products and literature ✅Identifying and addressing implementation hurdles ✅Building a strong business case for PCM DS Secure your spot today: https://hubs.ly/Q02QlmNy0 #Pharmaceuticals #ContinuousManufacturing #DrugSubstance #PCM