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Regulatory Affairs Services

  • Drawing up and implementation of standard operational procedures (SOPs)
  • GLP/GMP/GDP implementation & training
  • Preparation for GLP/GMP/GDP-auditing & -inspections
  • Interpretation of guidelines
  • Writing of proposals (e.g. orphan drugs)
  • Procurement of documents for Scientific Advice and accompaniment at Pre-submission Meetings
  • Generation of files (IB - IMPD - CMC - DMF - CTD) and study plans including quality management manuals.

Links
EMA, EMA-News
Search Clinical Trials
Biotechnews