Expert CMC, Quality and Regulatory Support

Move Forward with Confidence

What Challenges are you Facing?

Biologics & TIDES

Advance your biologics or TIDES with tailored CMC, regulatory, and quality expertise. Pharmatech Associates helps you overcome production and compliance hurdles to achieve timely approvals and long term market success.

Cell & Gene Therapy

Bring advanced therapies to patients with confidence. Our team supports you with risk based control strategies, regulatory alignment, and quality frameworks that address the unique complexities of cell and gene therapy development.

Combination Products

Integrate drug, device, and biologic components into safe, compliant combination products. Pharmatech provides strategy and execution across human factors, regulatory pathways, and quality systems to streamline approval and launch.

Small Molecules

Navigate evolving standards in small molecule development with proven expertise. We help you accelerate approvals, solve manufacturing challenges, and strengthen quality systems to keep your products on the market.

Quality & Compliance

Design and implement quality systems that scale with your program. Pharmatech supports QMS development, gap remediation, inspection readiness, and supplier oversight to ensure compliance at every stage.

Regulatory Affairs

Confidently move from IND to approval with expert regulatory strategy and execution. Our team helps you plan pathways, prepare submissions, and engage with agencies worldwide to accelerate timelines and reduce risk.

Product Development & CMC

Turn innovation into commercial success with integrated CMC strategies. Pharmatech partners with you from early development through scale up to design control strategies, manage tech transfer, and align with regulatory expectations.

Continuous Manufacturing

Transform your operations with continuous manufacturing. We help you design and implement efficient, compliant processes that improve quality, lower costs, and reduce environmental impact.

Facilities Design & Validation

Build or expand facilities with regulatory confidence. Pharmatech guides you from design through commissioning, qualification, and validation to achieve inspection readiness and operational success.

US Market Entry

Prepare your program for successful FDA review and commercialization. We bridge global to US regulatory gaps, align CMC strategy, and support long term market growth and manufacturing readiness.

In Silico Modeling

Leverage AI powered digital modeling to reduce risk, compress timelines, and cut costs. Pharmatech helps you anticipate CMC challenges before they surface, accelerate IND preparation, and strengthen regulatory confidence.

Due Diligence & In Licensing

Evaluate pharmaceutical assets with confidence. Pharmatech Associates provides technical and regulatory due diligence for drug substance, drug product, M&A, and in licensing transactions. We identify risks, validate opportunities, and deliver clear strategies to protect and enhance deal value.

Our Approach

Our unique approach is the key to navigating the complexities of drug development for global markets. The Pharmatech Ecosystem describes our fully integrated knowledge and understanding of the product development lifecycle.

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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 in mind.

Ready to Grow

We design solutions that support your next product, your next site and your next market, not only the project in front of you.

Contact Us

Let’s Get Started

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