AN APPROACH
We solve problems
CEO /
Owner
Owner
- Audit of the regulatory system and the status of the dossier
- Turnkey procedures control
- Pharmacovigilance function
- Writing Clinical Development Plan
Medical
Director
Director
- Determination of the type of medicinal product
- Preparing a dossier (medical writting)
- Production licensing and GMP
- Development and support of Clinical Development Plan
QPPV and pharmacovigilance manager
- Pharmacovigilance system audit
- Medical writting - RMP preparation, DCO (AddCO), PSUR
- Preparation of Pharmacovigilance and SOP System File Wizard
- Creating and maintaining a hotline
- Pharmacovigilance training
Regulatory
Manager
Manager
- Determining the type of procedure
- Medical writing - preparation of a review of preclinical data
- Tracker of regulatory procedures
- Development and support of Clinical Development Plan
Registration of medicines
- Registration and re-registration of medicines, medical devices, dietary supplements
- Management of safety and quality of medicines
- Licensing and certification of production
Drug Safety Reports
- We prepare reports on drug safety in 3 languages - Russian, Ukrainian, English
- Risk Management Plan (RMP)
- Addition to the Clinical Data Review (ACO - Addendum to Clinical Overview)
- Periodic Safety Report (PSUR - Periodic Safety Update Report)
Reviews and resumes
- Quality/Quality Overall Summary
- Nonclinical Overview/Nonclinical Summary
- Clinical Overview/Clinical Summary
Pharmacovigilance
- Authorized person responsible for pharmacovigilance - QPPV
- Preparation of a master file pharmacovigilance system
- Telephone hotline
- Pharmacovigilance training
Development
- Roadmaps of preclinical, clinical research and registration
- Preclinical and clinical trial protocols
- Bio-statistics
High-tech IT platform for pharmacovigilance and regulatory
- Ability to simultaneously connect up to 100 users of one client.
- Saving pharmacovigilance data in E2B r2 format.
- Structuring data in CTD format
- Access from any mobile device 24/7
We help to prepare all the necessary documents for the registration of medicines, medical devices, dietary supplements, and cosmetic products