Regulatory Affairs & Clinical

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Our regulatory affairs services are based upon a rigorous foundation of technical, scientific, and compliance understanding. Pharmatech’s regulatory and clinical team has expertise in all aspects of development for biologics, cell/gene therapy, small molecule, medical devices, combination products, veterinary products, and cosmetics. Our work begins with developing a comprehensive regulatory strategy for the successful development, evaluation, and commercialization of innovative products.

Our experienced staff has the expertise to support your product lifecycle through Chemistry, Manufacturing, and Controls (CMC) development, nonclinical studies, clinical trials, interactions with health authorities, marketing authorization submissions, post-approval requirements, stakeholder management, mergers, and acquisitions. We are committed to providing our clients with clear and comprehensive regulatory guidance, effective technical writing, and productive communication with regulatory bodies.

Our priority is maximizing opportunities for our clients through collaboration and meeting key milestones on time and within budget.

We provide these regulatory services:

REGULATORY STRATEGY

HEALTH AUTHORITY INTERACTIONS

WORLDWIDE CLINICAL TRIAL AND MARKETING AUTHORIZATION APPLICATIONS

STAKEHOLDER MANAGEMENT, AND MERGERS & ACQUISITIONS

 

pharmaceutical vials and pills

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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

22320 Foothill Blvd. Suite 330, Hayward CA 94541