Global Regulatory Affairs
Bolstered by its acquisition of Impact Pharmaceutical Services in early 2022, Syner-G BioPharma Group can provide complete global regulatory affairs services across all phases of product development, as well as post-approval. Our services include developing and implementing global regulatory strategic plans, CMC regulatory strategy and tactical solutions, regulatory agency meeting support, and electronic submissions to regulatory authorities around the world. Our deep, diverse group of expert consultants has both academic and hands-on experience in the US and abroad. Whatever your challenge, it’s likely our team has not only experienced it, but they’ve also conquered it. These professionals, many of whom are PhDs, are passionate about providing expert guidance that spans the regulatory landscape.
Our honest, transparent, and flexible approach creates an atmosphere of mutual respect and trust that leads to lasting relationships. Clients typically consider us as an extension of their own project teams. For small or virtual companies, we can BE your global regulatory affairs department.
We take pride in our ability to manage all regulatory aspects of your drug development program, from global regulatory strategy development to regulatory representation on product development teams, IND submission and maintenance, and Regulatory Agency interactions. Our expertise in all aspects of regulatory affairs runs deep.
Syner-G has the expertise and experience to format, compile, publish, and submit all of your required regulatory documents via FDA’s Electronic Submissions Gateway (ESG). We have SOPs in place to ensure quality and we use a validated, 21 CFR Part 11 compliant electronic document management system.
The CMC regulatory landscape is continuously evolving and presents a steady challenge to the development of new small molecules, biologics, cell and gene therapies, and medical devices. We are experienced and passionate in helping our clients to design, plan, and execute CMC strategies critical for the successful development of new drugs.