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Medical and technical writing

We offer the assistance of a big and professional team in the development of medical, scientific and technical documentation. We have deep knowledge of both Ukrainian and European legislation requirements concerning different parts of the registration dossier. We are ready to perform works on selection, analysis, writing and verification of documentation.
 
We are ready to develop the following parts of the registration dossier:

1.8.1. Brief description of the pharmacovigilance system.
1.8.2. Risk management system (RMP);
2.3. Quality overall summary;
2.4. Pre-clinical overview;
2.5. Clinical overview;
2.6. Pre-clinical summary;
2.7. Clinical summary;
Modules 4 and 5: search or analysis of the documentation provided and formation of Modules 4 and 5 on the basis of bibliographic data and/or the manufacturer’s on research.
 
We are ready to develop the following pharmacovigilance documents:

  • RMP - Risk Management Plan;
  • PSUR - Periodic Safety Update Report;
  • PBRER - Periodic Benefit-Risk Evaluation Report;
  • ACO - Addendum to the Clinical Overview.

We are ready to develop the following pharmacovigilance quality system documents:

  • Pharmacovigilance system master file;
  • Pharmacovigilance Quality Manual;
  • QPPV job description;
  • QPPV regulation;
  • SOP, job descriptions, policies;
  • Logs, plans, records, registers, forms.

Other types of works:

  • search for scientific data about the efficacy and safety of the medicinal product and adverse effects in open and closed medical libraries;
  • development of documentation for Health Technology Assessment (HTA) for entering the medicinal product in the National list of main medicinal products of Ukraine.

 

Our services

Since 2006 we support the pharmaceutical business in regulatory affairs, pharmacovigilance, and quality. We are a leading regulatory consultant in Ukraine and 11 countries of the CIS region. Our extensive team has the necessary knowledge, experience, and skills and is proficient in English.
 
We have provided regulatory services for more than 200 manufacturers of medicines, many of which recommend us as a regulatory partner. 
 
We offer: 

In addition to the main services, we also offer:

We provide preliminary consultations free of charge. Call us +38 (068) 064-78-31, +38 (044) 223-61-67, email us at info@cratia.ua or visit our office.