Telephone: +44(0)1353 774000
E-mail:enquiries@globalregulatoryservices.com

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.

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Global House, Painters Lane, Sutton, Ely,
Cambridgeshire, CB6 2NS, UK
Telephone: +44(0)1353 774000
E-mail: enquiries@globalregulatoryservices.com