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Medical products and dietary supplements registration services
Pharmaceuticals registration
Short list of documents:
- Certificate of authority for the conduct of registration
- Pharmaceutical product certificates; certificates of free sale; certificate of registration in the manufacturing country
- Manufacturing license; GMP certificate
- Production scheme; Normative documents on the quality control of the pharmaceutical substance and adjuvants
- Normative documents on the control of the quality of the ready-made pharmaceuticals, procedures validation
- Stability data
- Reports on toxicity, clinical and other trials
- Reports on the studies of pharmacokinetics, pharmacodynamics, carcinogenicity and others
The complete list of required documents with detailed explanations is provided upon the signing of the contract.
Cost of service — ...
Pharmaceutical substances registration
Short list of documents:
- Certificate of authority for the conduct of registration
- Document, confirming registration of the pharmaceutical substance in the manufacturing country
- Manufacturing license (GMP certificate)
- Brief production scheme; Normative documents on the quality control
- Trials report and ЛФФА opinion letter
The complete list of required documents with detailed explanations is provided upon the signing of the contract.
Cost of service — ...
Products of medical purpose and medical equipment registration
Short list of documents:
- Certificate of authority for the conduct of registration
- Documents, confirming quality and safety of the declared product, their origin
- Operation and exploitation sheet
- Price-list of the manufacturer, advertising pamphlet on the declared product and other
The complete list of required documents with detailed explanations is provided upon the signing of the contract.
Cost of service — ...
Dietary supplements registration
Short list of documents:
- Certificate of authority for the conduct of registration
- Manufacturer's documents on the quality and safety of the product
- Package design
- Ingredient composition
- Sanitary examination statement
- Contract (foreign trade agreement) or another product delivery agreement.
The complete list of required documents with detailed explanations is provided upon the signing of the contract.
Cost of service — ...
Perfume and makeup preparations registration
Short list of documents:
- Certificate of authority for the conduct of registration
- Manufacturer's documents as well as those from local healthcare authorities, confirming quality and safety of the declared product
- Ingredient composition
- Sanitary examination statement; certifying body resolution (in case the product is subject to certification)
- Contract (foreign trade agreement) or another product delivery agreement
The complete list of required documents with detailed explanations is provided upon the signing of the contract.
Cost of service — ...
