If you are advancing a monoclonal antibody, biosimilar, bispecific, peptide, oligonucleotide, antibody-drug conjugate (ADC), you are likely navigating complex development, manufacturing, and regulatory hurdles, often across multiple health authority frameworks. For ex-U.S., sponsors and biosimilar manufacturers entering the U.S., success requires more than a strong dossier: FDA expectations for comparability, analytical similarity, process control, and inspection readiness must be met from day one. For ADCs and advanced modalities, controlling impurity profiles, potency, conjugation variability, and sterile operations can become the rate-limiting step.
Pharmatech Associates, a USP company, works alongside you to clear those hurdles with an integrated approach that connects CMC, regulatory strategy, quality systems, and operational readiness. We translate evolving expectations into practical, buildable plans—spanning development strategy, tech transfer and CDMO oversight, commissioning/qualification/validation readiness, and inspection preparation, so the science, the process, and the quality system tell one coherent, regulator-ready story. The result is fewer surprises, faster progress to key milestones and approval, and a smoother path to reliable commercial supply.
Every biologics or TIDES 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 and TIDES from concept to clinic.
You gain support with:
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
Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583
