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.