Pharmaceutical documentation

We have a team of professionals with high-level academic education combined with a long work experience in different fields of pharmaceutical industry. Our experts have worked with API and drug product development, assessment of documentation at the Finnish Medicines Agency, and writing of pharmaceutical chemical documentation in the pharmaceutical industry.

We have expertise in human and veterinary medicinal products, sterile and non-sterile products and biopharmaceuticals. More than 20 scientific experts are ready to give their knowledge and skills to your use. Our pharmaceutical chemical documentation expertise is strengthened even further by regulatory and eSubmission intelligence, resulting in high-quality documents submitted as eCTD, NeeS or VNeeS.

Services

  • Marketing authorisation applications
    • • Writing of new Module 3 (or Part II) documentation
    • • Preparation of Quality Overall Summaries
    • • Evaluation and/or updating of existing Module 2.3 and 3 documentation
    • • Change of documentation format, e.g. from NtA to CTD format

  • Renewals

  • Variations
    • • Consultation and problem-solving
    • • Comparisons between existing and proposed Modules 3
    • • Classification of variations
    • • Writing of variation documents:
      • From single variations to complex variation packages

  • Requests for supplementary information
    • • Consultation
    • • Writing of responses

  • FDA (U.S. Food and Drug Administration)
    • • Writing of pharmaceutical chemical documentation
      (New Drug Application / Abbreviated New Drug Application or
      New Animal Drug Application / Abbreviated New Animal Drug Application)
    • • Changes to an Approved NDA or ANDA (supplements)
    • • Annual reports (for animals, Minor Changes and Stability Report)

  • Active Pharmaceutical Ingredient (API)
    • • Update of Active Substance Master File (ASMF) documents
    • • Support for applications for Certificates of Suitability (CEPs)
    • • API stress tests and API stress test plans and reports
    • • ICH stability studies and stability study plans and reports
    • • Development and validation of methods of analysis
    • • Assessment of methods of analysis
    • • Validation plans and reports

  • Stability studies
    • • Stability protocols and reports
    • • Arrangement, management and coordination of stability studies
    • • Development and establishment of stability study systems and policies (e.g. facilities)
    • • Implementation of guidelines and standard operating procedures for stability study policies
    • • Training in stability study related topics

  • Translations
    • • Manufacturing instructions
    • • Descriptions of analytical methods
    • • SOP documents

  • Manufacturing process validation
    • • Qualification protocols and reports
    • • Validation protocols and reports

  • Dossier evaluation for business purposes
    • • Gap analysis
    • • Due diligence

  • GMP
    • • Support, consultation and training
    • • Writing of documents

  • Pharmaceutical chemical documentation for clinical trial applications
    • • EU: IMPD (Investigational Medicinal Product Dossier)
    • • U.S.: IND (Investigational New Drug)

For more information please contact

Manager of Pharmaceutical Chemical operations Ulla Orava