If you are advancing a monoclonal antibody, a biosimilar, a bispecific, or an innovative modality such as an antibody-drug conjugate, you are likely facing complex development and regulatory hurdles. Each delay means more time before patients receive the therapies they need.
Pharmatech Associates, a USP company, works alongside you to clear those hurdles. With expertise in CMC, regulatory strategy, and quality systems, we help you move from early development to approval with clarity and confidence
Every biologics program is different. We begin by understanding your stage, objectives, and challenges. Together we define milestones and build a clear development roadmap, supported by experts who know how to bring biologics from concept to clinic.
You gain support with:
You are partnered with specialists who bring decades of hands-on global experience in biologics development, CMC strategy, and regulatory affairs
A sponsor with a complex glycan profile needed to meet a tight BLA timeline. Working together, we validated a scale-down model and defined reproducible parameters.
Impact for the client:
✔ BLA submitted on schedule
✔ Critical CMC gaps closed
✔ FDA approval achieved
Regulatory expectations can feel like a moving target. We help you anticipate what agencies will require, close any gaps early, and prepare packages that stand up to review. With our guidance, you can move forward knowing your submission is built to succeed
We gained breakthrough designation and shaved months off approval
A client with strong Phase I results wanted to pursue accelerated pathways. We aligned their CMC plan with breakthrough therapy requirements, delivered GMP lots suitable for Phase II, and refined analytics to ensure readiness.
Impact for the client:
✔ Breakthrough designation granted
✔ FDA approval 3–6 months earlier
✔ Zero CMC issues raised
Biologics often blur the lines between therapeutic classes, and one-size approaches rarely work. We help you design quality frameworks that are right for your stage, your facility, and your goals. This includes supplier oversight, audits, QbD strategies, and hands-on operational support. With the right foundation, you can advance with fewer surprises later
We achieved fast-track approval in just six months
A company preparing for IND wanted to pursue fast-track designation. Together we built a risk-based CMC plan, secured early FDA engagement, and simplified downstream submissions.
Impact for the client:
✔ Fast-track designation granted
✔ Approval in only six months
✔ Streamlined CMC accepted
Whether you are at the earliest stages of development or preparing a submission, Pharmatech Associates can help you move forward with clarity, speed, and confidence
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
