US Food & Drug Administration (FDA) Regulatory Support

Global Regulatory Services has developed strong links with America so that we can offer regulatory affairs support to our non-American clients who are looking to market their medicines in the US.  We are able to provide a full range of regulatory and clinical services to the Pharmaceutical and Biotechnology Industries which include:

  • Consulting on chemistry, manufacturing, and control (cGMP)
  • Contract clinical monitoring
  • Auditing of clinical sites and preparing them for regulatory audits
  • Program Management for pre-clinical and clinical development programs
  • Timeline assessments and cost development analysis
  • Strategic research planning for a single product or portfolio
  • Regulatory affairs consulting
  • Competitive intelligence monitoring
  • Protocol design and methodology
  • Managing scientific advisory boards
  • Assessing technical and economical feasibility of a single product or portfolio
  • Assessing the probability of technical and regulatory success
  • In-licensing and out-licensing
  • Assisting new business development in technical feasibility assessments
  • Medical writing

Please contact us with your specific regulatory compliance requirements.