PharmConsult LLC provides you with all-round support in gaining of the CIS pharma market
From advice and guidance to the full-spectrum regulatory support,
we focus on the following services:
Registration and Submission Support
- Registration Dossier Preparation (in Russian, English and other languages if needed)
- Adaptation of Documentation in Compliance with the CIS Legislation (Belarus, Kazakhstan, Russian Federation)
- Primary and Secondary Packaging Mock-up Preparation
Life-cycle Management of Regulatory Documents
- Dossier Submission
- Organization of Preclinical and Clinical Research, if needed.
- Obtaining of Permits and Handling Official Queries and Resolutions
- Preparing Answers, Reports in accordance with Queries
Outsource Service of pre-registration and post-marketing pharmacovigilance in the Republic of Belarus, including:
- Assignment of a Qualified Person for Pharmacovigilance;
- Safety Monitoring of Marketed Medicinal Products;
- Literature Screening for Adverse Events Detection;
- Preparation of Periodic Safety Update Reports and other documentation
Translation & Medical Writing - Linguistic Support you can rely on
- All our translators are qualified to an MSc, Ph.D. or MD level and have at least 5 years of experience translating medical documents.
- Your sensitive and confidential documents are safe with us. We use secure file systems, and all of our translators work under a binding NDA.
- We meet and exceed translation quality standards, and guarantee our translations will be error-free, or we'll update them free of charge.
- Evaluation of the need in the investigated medicinal product on the local pharmaceutical market and its sales potential by conducting sales-dynamics research and analysis for various treatment group product in retail, hospital, and reimbursement segments
- We want to make your entry to CIS pharma market smooth and successful. We are ready to be your dependable partner and provide you any help and consulting needed to reach these goals.
CONTACT US NOW
+375 44 783 55 74 (tel)
+ 375 17 372 45 56 (tel/fax)