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Comprehensive Regulatory and Medical Writing Services according to applicable regulations and ICH-guidelines
(for drugs and medical devices)

· Clinical study reports (CSR) including CSR synopses for
  public disclosure

· Pre-clinical and clinical parts of investigational medicinal
  product dossiers (IMPD)

· Investigator brochures

· Summary of product characteristics (SmPC)

· Patient information leaflets (PIL)

· Informed consent documents

· Patient safety narratives for clinical study reports

· Clinical study protocols and amendments

· Literature summaries

· Editing/proofreading including source data verification of
  all pre-clinical/clinical documents

Regulatory Compliance Services
tailored solutions to meet your regulatory needs

· Review of all documents needed for clinical trial applications
  (CTA) – Review of stand-alone documents as well as checking
  the consistency of all documents of the application dossier

· Support with replying to CTA deficiency letters

· Update of product information, e.g. SmPC and PIL
  (after a referral has taken place)

· Support with classification of products (borderlines), e.g.
  medicinal product, medical device, cosmetics, food additives

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