When it comes to reliable outsourcing for regulatory affairs for pharma, OneSource has the expertise and support you need to support your product launch! We help you save money and time by using our services to augment or outsource your regulatory functions. You can learn more about OSR’s high-value regulatory services here.
REGULATORY AFFAIRS FOR PHARMA COMPANIES
OneSource Regulatory provides high-value regulatory services for small, medium, and large pharmaceutical companies. These include:
- Regulatory Advertising & Promotion Review to ensure you meet FDA requirements while differentiating your product for commercialization
- Technology-enabled Labeling development (TPP, DCDS, CCDS, and local label development, including the US PI and the EU SPC and PIL)
- CMC – support the planning, execution, and writing of the CMC sections (drug substance and drug product) for US and international regulatory submissions
Our team is made up of specialized individuals and qualified leadership. Our co-founders have been where you are now, and understand the challenges you face as a pharma company. As experienced industry leaders, we pride ourselves on being more than just a placement firm when it comes to outsourced regulatory affairs for pharma. We only hire the very best, and oversee the work they do at all our client companies.
PROACTIVE ASSISTANCE & UNIQUE SUPPORT LEVELS
Because of our vast pharma experience, we offer support in a variety of ways. This includes:
- Staff augmentation
- Full/partial outsourcing
- Flexible staffing
- Pharmaceuticals (Rx and OTC)
- Animal Health (Rx and OTC drugs; biologics)
- Nutritional Supplements
Our goal is to provide dependable, reliable regulatory services and advice at the click of a button. We are innovating the pharma industry, one service at a time. Learn more about our experienced leadership and our mission here.
We’d love to set up a free discussion with you about your company’s needs.