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: 

• consultation, development of registration strategy;
• establishment of new registration, renewals, and variations;
• establishment and maintaining a pharmacovigilance system, outsourcing the functions of the local contact person;
• confirmation of manufacturing conditions with GMP requirements through recognition or inspection.

In addition to the main services, we also offer:

• translation of the scientific, medical, technical, and legal documentation;
• back-office operations: preparation of the registration dossier or any of its parts without submission;
• development and pre-printing verification of labeling artworks and instructions for use;
• medical writing of parts of the registration dossier;
• development of documentation and import licensing;
• writing of documentation for inclusion of the medicinal product in the National List (HTA).