Regulatory Affairs & Clinical
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 budget. We provide these regulatory services:
HEALTH AUTHORITY INTERACTIONS
WORLDWIDE CLINICAL TRIAL AND MARKETING AUTHORIZATION APPLICATIONS
STAKEHOLDER MANAGEMENT, AND MERGERS & ACQUISITIONS