From early-stage innovation to commercial launch, product and process development brings both opportunity and risk. Programs often face challenges in scalability, yield, quality, and regulatory expectations. Without the right control strategy, delays and costly redesigns are common. Pharmatech Associates, a USP company, helps you build confidence in your development pathway. Our multidisciplinary team supports product, process, and analytical development, device integration, and CMC alignment, all designed to accelerate timelines and reduce program risk
Every program shares one goal: successful commercial scale-up. We start with a gap analysis of your controls, procedures, and process maturity against global expectations. From there, we create a roadmap and provide hands-on support to prepare you for clinical and commercial milestones.
Case Study: Comprehensive Assessment Leads to FDA Alignment
A biosimilar sponsor engaged Pharmatech for process development and validation planning. We aligned their cell bank characterization strategy, authored development plans, and guided contract testing.
Impact for the client:
✔ Biosimilarity successfully demonstrated
✔ Robust control strategy established
✔ FDA alignment achieved without delays
Case Study: Redevelopment Success Without FDA Findings
A biologics client needed to transition five therapies from PHSA Section 351 to Section 361. We redesigned facilities, validated equipment, remediated QMS gaps, updated INDs, and guided development post-transition.
Impact for the client:
✔ Three INDs advanced successfully
✔ Zero FDA observations during audit
✔ Development continued without disruption
Scaling to commercial production often involves tech transfer, CDMO oversight, or vendor transitions. Each step carries risk if not carefully managed. Pharmatech Associates, a USP company, ensures your documentation, protocols, and validations transfer smoothly so production remains compliant and reliable
Case Study: Eight Programs Transferred Without Delay
A CGT CDMO engaged Pharmatech to relocate manufacturing and analytical processes for eight therapies. We managed risk assessments, authored protocols and batch records, and oversaw readiness activities.
Impact for the client:
✔ All eight programs successfully transferred
✔ Regulatory alignment maintained
✔ Audit-ready transition completed on schedule
Pharma 4.0 technologies create opportunities for smarter control and oversight. We help you integrate automation, data science, and AI-driven tools to enhance analytics, predictive modeling, and process monitoring. The result is a program that is both compliant today and digitally optimized for tomorrow
Whether you are designing a control strategy, preparing for regulatory submission, or scaling to commercial supply, Pharmatech Associates, a USP company, provides the expertise you need
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
