From early innovation to commercial launch, development creates both opportunity and risk. An effective control strategy must do more than set specifications. It should integrate advanced modeling, digital tools, and data analytics so teams can anticipate scale up, tech transfer, and device integration challenges before they reach the plant. Built to withstand multiproduct operations, global supply networks, and post approval change, the control strategy supports comparability, continuous improvement, and efficient responses to evolving regulatory expectations.
Our multidisciplinary team of senior experts designs your product and process control strategy with clear line of sight to quality and regulatory requirements. We provide integrated support across product, process, analytical development, device integration, and CMC alignment within a full lifecycle framework. Senior led, focused assessments replace broad risk lists and reduce the internal ramp up required. The result is sharper analysis, clearer decision options, stronger inspection readiness, and a more resilient commercial supply over the product’s life.
Our Focus Areas Include:
• CMC and regulatory submission strategies
• Process and analytical control strategies
• Quality control laboratory and method life cycle management
• Critical material and vendor management
• Equipment design and validation
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
Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583
