Regulatory Affairs Pharma

Regulatory Affairs is a profession within regulated industries such as pharmaceuticals, biological, medical devices, cosmetics, natural health products and foods.

Goals of Regulatory Affairs

  • Protection of human health
  • Ensuring safety, efficacy and quality of healthcare products
  • Ensuring appropriateness and accuracy of product information

Roles of Regulatory Affairs

  • Act as a liaison with regulatory agencies
  • Keep track of the ever changing legislation
  • Prepare and submit organized and scientifically valid regulatory documents
  • Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws
  • Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans
  • Advising the companies on regulatory aspects and climate that would affect their proposed activities

Regulatory Landscape and Product Development

Step 1: Properly classify the healthcare product

Step 2: Identify the claim of the healthcare product

Step 3: Determine your market

Step 4: Development the regulatory strategy

Step 5: Establish the product development plan

Step 6: Execute the product development plan/clinical plan

Step 7: Collect the data for regulatory submission

Step 8: Collate the regulatory submission to applicable regulatory requirements

Step 9: Ensure post-marketing compliance

Concept 2 Clinic’s Regulatory Program 

The development of healthcare products (e.g. drugs, NHPs and medical devices etc) is gaining momentum with the perspectives of safety, efficacy, and quality for improvement and promotion of health of human beings. Our experts provide regulatory strategy and support from the preclinical stage through to market, including content authoring, and preparation, submission and maintenance of applications for registration of pharmaceuticals, biologics, natural health products (NHPs), dietary supplements, cosmetics, medical devices and food additives and ingredients in the United States, Canada and China.

Contact Us Today to learn more about how our variety of Regulatory Affairs/Quality services can benefit your project!