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
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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