Your partner in new drug R&D
Documentation writing

Preparation of scientific and regulatory documents

We can prepare for you any of the documents listed below. We will prepare them using our professionally designed templates, in full compliance with the regulatory requirements.

  • Standard Operating Procedures (SOP)
  • Manufacturing Instructions
  • Batch Records
  • Clinical and Non-Clinical Protocols
  • Investigational New Drug (IND) and Clinical Trial (CTA) applications in compliance with the USA, Canadian and European Union requirements
  • Pre-IND information packages
  • New Drug Development Master plans (see more details here)
  • Investigator's brochures
  • Investigational Medicinal Product Dossiers (IMPD)
  • Informed consent forms
  • Scientific literature reviews