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 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.

• 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.

• Receiving import permission;
• Solution of import problems caused by mistakes in registration documents;
• Import control of the first series delivered at registration.

• 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.

• 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.