Your result is our work
Reliable and experienced consulting partner in the pharmaceutical market
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MFG is ready to go through all the steps to bring the product to market. GMP certification. Research. Check in.
Debugged system
of interactions
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We find the right solutions in work processes and dialogues with regulatory authorities and partners.
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We value our time and yours. Therefore, we try to implement each project as soon as possible.
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A strong, well-coordinated team with more than 200 successfully completed projects.
Our services
Medicines, API, Food supplements, Medical products
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Drugs and API registration:

  • Due to our long term cooperation with regulatory authorities we will make your; registration cost and time effective;
  • Our specialists adapt and prepare registration documents for submission to Ministry of Health and also supervise the registration at all stages;
  • Clinical trials arrangement (CT);
  • Minimizing the amount of Clinical trials;
  • Prices registrations and changes in the State register.

Food supplements registration:

  • Checking the composition of Food supplements ingredients to determine the potential for product registration;
  • Review by experts and confirmation of the possibility of registering the composition of interest or receiving recommendations for changing the composition;
  • Preparation of the necessary documents for the registration of Dietary supplements, both for the Russian manufacturer and for a Foreign manufacturer;
  • Preparation registration documents for submission to Rospotrebnadzor (Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing);
  • Supervising the expertise at all stages.

Medical devices registration:

We fully undertake cooperation with Roszdravnadzor (Federal Service for Surveillance in Healthcare) and expert organizations on registration of medical devices.

  • Analysis and evaluation of primary documentation, its adaptation for compliance with the requirements of the regulator;
  • Preparation and organization of Toxicological and technical tests;
  • Elaboration of comments from expert organizations and preparation for clinical trials;
  • Obtaining permission to import samples;
  • Translation of the necessary documentation for the registration dossier;
  • Control of documents passing during the examination.
GMP audit
Getting ready to GMP audit
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GMP audit
  • GMP compliance pre-audit of pharmaceutical manufacturing sites and their partners.
  • Organization and conduct of pharmaceutical audit at the place of activity (production sites) of production of medicines (drugs).
  • Audit is conducted by certified professionals (4 certificates are issued by the experts of European Union including PIC/S).
  • Conducting training programs for training specialists in GMP, GDP, GLP.
  • Preparation of a set of documents for submission to the Ministry of industry and trade of Russia for State audit.
  • Support of the State audit with a visit to the manufacturing site.
  • Submission of documents to the Ministry of industry and trade of Russia for receiving the Russian GMP certificate.
Authorized representative for Pharmacovigilance
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  • The company provides a full range of Pharmacovigilance services.
  • If necessary, our company is ready to become the Authorized representative for Pharmacovigilance and Claim Receiver in Russian Federation.
Import and skip testing
Procedure for importation of medicines
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Import and skip testing
  • Receiving import permission;
  • Solution of import problems caused by mistakes in registration documents;
  • Import control of the first series delivered at registration.
Clinical trials
Organization of Clinical and Bioequivalence studies
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Clinical trials
  • Arranging Clinical Trials (CT), bioequivalence studies (be), STCR;
  • Arranging worldwide multicentral clinical trials;
  • Minimization the amount of CT;
  • Conducting trainings on the program Good clinical practices (GCP);
  • Preparation of documents for the clinical trial (including Protocol writing, investigator brochures, and more);
  • Selection of clinical bases for research;
  • Involving key opinion leaders and industry’s influencers.
Additional services for pharmaceutical companies
Analysis of the product portfolio, pricing, channels of distribution
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Additional services for pharmaceutical companies
  • Searching products for your portfolio;
  • Comprehensive testing of each product and evaluation of its prospects;
  • Choosing an API suppliers and contract manufacturing;
  • Selection of manufacturers of drugs and support of transactions under license agreements and exclusive distribution contracts;
  • Developing the strategy of product promotion;
  • Development of product pricing policy;
  • Analytical review of the company’s product portfolio;
  • The choice of supply chain;
  • Help with opening representative Offices in Russia;
  • Trainings for Marketing, Sales and Registration departments;
  • Carrying out all necessary registration actions for receiving MA in the Russian Federation and the EU countries;
  • Market launch of innovative drugs on the principle: “from idea to product launch”;
  • Patent clearance of the drug.

Consulting services in marketing:

  • Formation of the strategy of product promotion;
  • Development of product pricing policy;
  • Analytical review of the company’s product portfolio.

Financial decision:

  • Project business plan;
  • Selection of financing programs and building relationships with the credit institution;
  • Development of a business plan or feasibility study (feasibility study);
  • Evaluation of the effectiveness of investment projects;
  • Monitoring of project implementation.
approach to work
Information synchronization for all participants of the process
developing product registration passport
which includes product key characteristics
Initial manufacturer documentation upgrade
registration dossier preparation
according to the authority experts
Minimizing the amount of Clinical trials
reducing time and costs
and transparency
Control and immediate feedback at all stages
MA in shortest
possible time
We follow the principles of compliance and care about your and our reputation the company respects the intellectual property of each client nda guarantees the confidentiality of your data
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