Contract Manufacturing

Pharmmental Group — Partner for Launching in Russia/EAEU: Manufacturing, Registration, and Distribution

We help marketing authorization holders bring their products to the markets of Russia and the EAEU.
We handle tech transfer, dossier adaptation, registration, GMP manufacturing, quality control, serialization, and market access through public procurement

Please send information about your drug so we can discuss a potential partnership

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Ideal Partner Profile

For IP holders looking for a partner with manufacturing and commercialization capabilities in Russia and the EAEU

Contract Manufacturing

Full-cycle contract manufacturing — from technology transfer to GMP-compliant finished product release, including packaging, labeling, and quality control

License

A partnership model where we localize and register the product under license, managing the entire manufacturing process and regulatory compliance

Exclusivity
Co-exclusivity

We assume full responsibility for the product’s market launch, promotion, and development, ensuring registration, marketing, and distribution across Russia and the EAEU

Our Advantages

We ensure a full cycle of pharmaceutical product launch and promotion — from technology transfer to commercial supply

Full Cycle

From agreement to distribution — we handle technology transfer, registration, GMP manufacturing, and logistics, ensuring quality control at every stage

Our Manufacturing Facilities

Aseptic manufacturing of solutions and lyophilized products, as well as production of solid dosage forms, aerosols, and APIs

Extensive Distribution Network

Proprietary warehousing and logistics infrastructure, including cold chain capabilities, with nationwide coverage and expertise in government tenders

Technology Adaptation

From agreement to distribution — we handle technology transfer, registration, GMP manufacturing, and logistics, ensuring quality control at every stage

step
1

Interaction with Regulatory Authorities

We support the expert evaluation process, prepare responses to regulatory queries, implement necessary adjustments, and liaise with the authorities until the Marketing Authorization is granted

step
4

Preparation of CTD/eCTD dossiers

We develop or adapt registration dossiers in compliance with the requirements of the Russian Ministry of Health and the EAEU, including the CMC section, quality reports, and safety data

step
2

Pharmacovigilance outsourcing

Upon market launch, we ensure safety monitoring, dossier variation management, labeling updates, and pharmacovigilance reporting

step
5

Clinical Trials

If required, we conduct preclinical studies and clinical trials (bioequivalence, pharmacokinetics, efficacy, and safety)

step
3

Technology Transfer and Registration

We handle technology adaptation, registration dossier preparation (CTD/eCTD), and conduct of local clinical trials if required. We also manage responses to regulatory queries, lifecycle management (variations), and Pharmacovigilance

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01. Contact Details

02. Product and Registration

Submit a Project 

Share your product details and partnership terms — we will contact you to discuss the market launch potential

03. Launch and Commercialization

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