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. We work with our clients to develop 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 maximize opportunities for our clients through collaboration and meeting key milestones on time and within budget.
Consider the impact on your time to market by more efficient regulatory interactions and shorter review timelines. Contact us.
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.
22320 Foothill Blvd. Suite 330, Hayward CA 94541