Contact information

Medical and scientific writing

For local and foreign manufacturers, we offer our assistance of a large and professional team in development of medical, scientific, and technical documentation. We have excellent knowledge of the Ukrainian and European legal requirements to various sections of the medicinal product registration dossier; we are ready to perform the work on selection, analysis, drafting, and verification of documents for medicinal product registration, safety management, and quality management.

Module 1:

1.2. Registration form.

1.3.2. Labeling.

1.3.3. Instruction for medical use.

1.5. Special requirements to different types of medicinal products.

1.5.1. Information on medicinal product with well-studied medical use.

1.5.2. Information on generic, hybrid medicinal product or biosimilar.

1.6. Environmental risk assessment.

1.8.1. Brief description of pharmacovigilance system.

1.8.2. Risk management system (RMP – Risk Management Plan).

Module 2:

2.3. Overall quality summary.

2.4. Pre-clinical data review.

2.5. Clinical data review.

2.6. Pre-clinical data summary.

2.7. Clinical data summary.

Module 3: development of quality control techniques on the basis of manufacturer's documents (QCM – national form).

Modules 4 and 5: analysis of documents and compilation of Modules 4 and 5 on the basis of bibliographic data and/or manufacturer's research.

 

Pharmacovigilance system documentation:

1.8.1. Brief description of pharmacovigilance system.

1.8.2. Risk Management Plan (RMP).

Periodic Safety Update Report – PSUR.

Addendum to clinical overview – ACO.

 

Other types of work:

-     search for scientific data on medicinal product effectiveness, safety, and adverse events – in open and closed medical libraries;

-     drafting of documents for submitting the Application for the medicinal product inclusion in the National List of Essential Medicinal Products of Ukraine.

 

For cooperation or consulting, please call +38 044 361-48-28, +38 044 221-71-29, write to info@cratia.ua or visit us at the office.