Cell and gene therapies are transforming medicine and offering hope for conditions once thought untreatable. But bringing these therapies to patients means navigating a uniquely complex path: evolving regulations, accelerated approval pathways, and the lack of established development frameworks. A single misstep can cost valuable time and momentum.
Pharmatech Associates, a USP company, partners with you to build risk-based control strategies, prepare regulatory submissions, and strengthen quality systems that withstand scrutiny. Our goal is to help you move confidently through development and deliver life-changing therapies to patients faster.
Unlike traditional biologics, cell and gene therapies often lack clear regulatory precedent. Success requires anticipating agency expectations and building the right systems early.
What you gain with Pharmatech:
Our team has guided leading cell and gene therapy innovators through INDs, BLAs, and global regulatory reviews. You benefit from hands-on expertise in regulatory alignment, process optimization, and quality oversight
A CGT client needed to manage five programs submitted under the biologics framework. We helped overhaul quality systems, update regulatory documentation, and redesign facilities.
Impact for the client:
✔ Zero FDA observations during surveillance audit
✔ Facility redesign completed for compliance and scalability
✔ Full QMS remediation and IND updates delivered
A CGT CDMO needed to transfer manufacturing and analytical methods for eight unique products. We conducted risk assessments, developed protocols, and created master batch records and SOPs.
Impact for the client:
✔ Successful tech transfer for all eight products
✔ Regulatory alignment maintained throughout
✔ Downtime minimized, operational continuity ensured
Cell and gene therapy development requires CMC strategies that can adapt to evolving regulations and complex biology. We help you design integrated control strategies that reduce risk, strengthen compliance, and support long-term commercialization.
Our focus areas include:
Bringing a CGT product to market requires precision, speed, and expertise. Pharmatech Associates works with you to overcome regulatory, technical, and operational barriers so you can deliver therapies that change lives
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
