Regulatory
FDA Expectations for Comparability in Biosimilars
How sponsors entering the U.S. can prepare a regulator-ready comparability story from day one.
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A USP Company · 30 Years of Compliance through Science®
Expert CMC, Quality
& Regulatory Support
Move Forward with Confidence.
Pharmatech Associates combines 30 years of hands-on pharmaceutical consulting with the strength of United States Pharmacopeia — helping manufacturers build compliant, resilient, patient-first medicines for global markets.
30
Years
Compliance through Science®
USP PartnershipFDA · EMA · PMDAISPE MemberPDA AffiliateICH Q-Series21 CFR Part 11ISO 13485GMP ExcellenceUSP PartnershipFDA · EMA · PMDAISPE MemberPDA AffiliateICH Q-Series21 CFR Part 11ISO 13485GMP Excellence
What Clients Tell Us
The problems we're hired to solve.
We're not generalists with a long menu. Clients call us when something specific is on the line — a 483, a stalled submission, a launch that has to land. Here's what that usually sounds like.
“We just got a Form 483 and don't know where to start.”
Rapid gap assessment, remediation roadmap, and inspection-ready response — led by people who've sat on both sides of the table.
Quality & Compliance
“Our submission keeps coming back with CMC questions.”
We rebuild the CMC story so reviewers say yes the first time — from development data to module 3 narrative.
Regulatory Affairs
“We need to enter the US market and the FDA expectations feel like a moving target.”
A clear, agency-aligned path from pre-IND to approval, run by former regulators and submission veterans.
US Market Entry
“Our process won't scale and quality is slipping.”
Integrated CMC, process, and quality redesign — so scale-up doesn't break what already works.
Product Development & CMC
How We Help
A focused set of services. Delivered by senior people.
Every engagement is led by a partner-level expert with decades of hands-on industry experience — not handed off to junior staff.
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Years of Experience
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Global Clients Served
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Products Successfully Approved
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Continents · NA · EU · APAC · LATAM
In Their Words
Meet the people who'll be in the room.
No account managers between you and the work. The senior consultants who scope your engagement are the same ones delivering it.
"We don't sell decks. We sit beside your team until the problem is actually solved."
— Bikash Chatterjee, Chief Science Officer · 30+ yrs CMC
Our Approach
The Pharmatech Ecosystem
Our unique approach is the key to navigating the complexities of drug development for global markets.
Patient First
We measure success by safer, more reliable medicines reaching patients — not just documents delivered.
Fast & Focused
We move quickly, stay close to your critical path, and adapt as your priorities change.
Integrated View
We connect product, process, facility, digital systems, and quality so decisions are made with the full picture.
Ready to Grow
We design solutions that support your next product, your next site, and your next market.
USP
Member of
A USP Company
200 years of standards.
30 years of execution.
200+
Years of USP standards
140+
Countries reached
USP Partnership
Backed by 200 Years of Standards Excellence.
In 2021, Pharmatech Associates became the consulting arm of United States Pharmacopeia — a globally recognized organization that has established drug quality standards for more than 200 years. As part of USP, we combine hands-on consulting with the strength of a global standards setter, serving clients worldwide working to build a safer, more resilient medicine supply.
Learn More About Us★ Limited Engagement
Celebrating 30 Years of Compliance through Science®
Join us in recognizing three decades of helping pharmaceutical manufacturers bring safe, high-quality medicines to patients worldwide.
Insights
View All Resources Latest Insights
CMC
Closing the Gap Between Process and Quality Systems
An integrated CMC and quality framework reduces surprises through inspection and approval.
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Continuous Mfg
Why Continuous Manufacturing is the New Baseline
Higher quality, lower cost, smaller footprint — and a regulator-friendly path.
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Ready to Move Forward?
Our unique approach helps you navigate the complexities of launching a drug, biologic, or medical device into multiple markets. The first step is connecting.