With OSR experts on your side, we make it easy for you to ensure your advertising and promotions meet all the required FDA guidelines. Getting the right FDA guidance for drug advertising is a critical step in launching your next product, and is the culmination of years of drug development work. You’ve put in significant time, effort, and experience into bringing your product this far – let us help you ensure it doesn’t go to waste. OSR will provide the professional FDA advertising and promotion guidance you need for a successful product launch.

GUIDANCE FOR ALL SIZES OF PHARMA COMPANIES

OneSource Regulatory provides high-value regulatory and compliance services for small, medium, and large pharmaceutical companies. We have the right expertise and support to help you find ways to differentiate your product in the marketplace.

Our services 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

EXPERT FDA ADVERTISING AND PROMOTION GUIDANCE / SUPPORT

Some Regulatory or Compliance firms act more like basic placement organizations when it comes to guiding pharmaceutical companies in Regulatory affairs. Not us – OSR is a specialized services firm, led by proactive co-founders who have years of Regulatory and Compliance experience behind them. We only hire the very best in the pharma compliance industry and we oversee the work they do at our client companies.

Contact our experts today to find out how we can help your organization. We’d love to hear about your programs, and discuss how our offerings can enhance and support your Regulatory affairs and Compliance programs.