SOLOREG provides a full range of services for the market entry of pharmaceuticals and dietary supplements from international manufacturers to the Russian, EAEU, and CIS markets.

OUR END-TO-END SERVICE INCLUDES:

✔ Market Research and Analysis

✔ Development of a Comprehensive Registration Strategy

✔ Management of all Required Registration Procedures for Pharmaceuticals and Dietary Supplements

✔ Conducting Preclinical and Clinical Trials

We manage the entire scope of necessary studies required for registration, including:

Bioequivalence (BE) Studies

Clinical Trial design and management

Biowaiver Justification

Preparation of Medical and Scientific Reviews

Compilation of Clinical and Non-Clinical Modules for the registration dossier

✔ Registration in the "Honest Sign" (Chestny ZNAK) Track-and-Trace System for the Marketing Authorisation Holder (MAH), manufacturer, and product

✔ Import and Customs Clearance of pharmaceuticals into the Russian Federation

✔ Market Release Procedures (Introduction into Civil Circulation)

✔ Pharmacovigilance Services

✔ Marketing and Product Promotion

PARTNERSHIP AND CO-INVESTMENT PROJECTS:
If the results of a joint market analysis conducted by the manufacturer and SOLOREG confirm the product's significant economic potential, we may consider joint venture and project co-investment opportunities.

FLEXIBLE PACKAGED SOLUTIONS:

We understand that every client's needs are unique. Therefore, you can opt for either our comprehensive end-to-end solution or select any stand-alone service from our portfolio. This allows you to achieve your specific goals while optimizing time and budget.

✔ End-to-End Solution: Full-cycle project management from concept to market.

✔ À La Carte Services: Select individual services such as product registration, "Honest ZNAK" system enrollment, or any other specific stage you require.