Regulatory Affairs Consultation

We provide extensive regulatory support which enables companies to plan and execute efficient preclinical and clinical programs at the highest required quality level in compliance with the regulatory requirements. Our services provide solutions for issues derived from the regulatory authorities’ regulations and guidelines during the development of pharmaceuticals whether these are new chemical entities, biologics including recombinants or cell therapy and immunotherapy products.

Our services include:

  • Development of regulatory strategy
  • Writing and reviewing preclinical protocols and documents
  • Planning, writing or reviewing regulatory submissions (g. DMF, IND, CMC, comparability)
  • Consultations with regulatory authorities (FDA, EMA, MOH).
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