Providing of advisory services for the organization and management of representative and marketing activities of pharmaceutical companies in Turkmenistan.
Consultation on registration of pharmaceutical products (substances, medical products, medical devices, medical equipments). Changes to the registration documentation of medical products and devices.
Consultation on participation in tenders for the purchase of very important medical products.
Consultation and support of representative activity of pharmaceutical companies “Turnkey”
Training of pharmaceutical companies to work as medical representatives
- Legal advice
- Language translations of pharmaceutical documents
Providing of advisory services for the organization and management of representative and marketing activities of pharmaceutical companies in Turkmenistan.
Order service- Marketing analysis of the market of Turkmenistan, drawing up a marketing report of medical products, medical devices, medical equipments for pharmaceutical companies.
- Support and promotion of business requests of foreign pharmaceutical companies in Turkmenistan, taking into account public opinion.
- Development of advertising and marketing products for pharmaceutical companies, taking into account the requirements of regulatory authorities of Turkmenistan.
- Development of packaging design for medicines and medical products, taking into account the requirements of regulatory authorities and the style of pharmaceutical companies.
- Consultations and support in representative activities of pharmaceutical companies in Turkmenistan.
- Support and consultations of pharmaceutical companies in participation in public and state events of Turkmenistan (Exhibition, seminars, lectures, professional meetings).
Consultation on registration of pharmaceutical products (substances, medical products, medical devices, medical equipments). Changes to the registration documentation of medical products and devices.
Order service- Preparation and formation of a dossier for registration, re-registration;
- Development, preparation of documents and formation of the registration dossier in the required format in accordance with the requirements;
- Registration of applications, letters and necessary documents;
- Verification of the source documents necessary for the organization of the implementation of the registration project;
- Documentation review and preparation for filing for registration;
- Collection, preparation and submission of documents in accordance with the requirements;
- Interaction with various government agencies on obtaining the necessary documents for registration dossiers;
- Participation in the development of quality standards, instructions for the use of medical products in accordance with the requirements ;
- Organization of sending and receiving in a particular country of the dossier and samples required for registration / re-registration / modification;
- Control of expertise stages, the timely provision of responses to the requests of experts;
- Keeping records of payment documents;
- Maintaining contacts with experts and registrars on drug registration issues;
- Maintain current document flow;
- Interaction with relevant departments of the company on registration issues;
- Selection and training of specialists in registration of finished medical products and medical devices, medical equipments.
- When forming a complete dossier without flaws, the registration cycle for one product lasts on average 5-6 months.
- Below are all the requirements and provisions for filing documentation for the registration of medical products, medical devices, medical equipments.
- Amendments to the registration documentation of medical products
- Amendments to the existing registration dossier for the drug. The qualifications and knowledge of the regulations and legislation of our experts allow us to connect to the registration process at any stage.
Scheme for reviewing requests for changes to the registration dossier for a medical products:
- Change analysis.
- Sabmit dossier with changes and justification.
- If necessary: additional researching.
- Experts report.
- Confirmation of changes from the regular authority.
- The approximate timeframe for making changes to the registration dossier for a medical product is 5-6 months, taking into account studies (if necessary) to confirm the safety of the drug.
Consultation on participation in tenders for the purchase of very important medical products.
Order service- Preparation of a package of documents for participation in tenders for the purchase of very important medical products;
- Delivery of a package of documents for participation in tenders for the purchase of very important medical products to regulatory authorities;
- Maintain and control the stages of the tender, the timely provision of responses to requests from regulatory authorities;
- Keeping records of payment documents for participation in the tender
- Timely informing pharmaceutical companies about the results of the tender by drawing up an official letter of appeal.
Consultation and support of representative activity of pharmaceutical companies “Turnkey”
Order service- Preparation of a package of documents for registration of the Representative Office of Pharmaceutical Companies in Turkmenistan.
- Delivery of a package of documents for registration of the Representative Office of pharmaceutical companies in Turkmenistan and control over the registration process.
Legal registration of the Representative Office of pharmaceutical companies in Turkmenistan.
- Recommendations on the selection of offices location, office furniture, etc.
- Organizational issues of renting premises of the Pharmaceutical Companies Representative Office in Turkmenistan.
- Consulting in the representative process of pharmaceutical companies in Turkmenistan
- Consultations on the selection of specialists and managers of the Representative Office of pharmaceutical companies in Turkmenistan, taking into account the requirements of regulatory bodies.
- We offer professional training for middle and senior staff on the work of medical representatives, sales specialists, marketers, etc.
- Business training for senior staff of medical representatives, sales specialists, marketing specialists, etc.
- Theoretical and practical training of medical representatives on drugs of pharmaceutical companies, taking into account the SWOT analysis of products.
Legal advice:
- Drafting letters of appeal to state regulatory authorities, consultations on resolving issues on appeals.
- Advising pharmaceutical companies on inspections of pharmaceutical activities by regulatory authorities, as well as supporting the preparation of documents before inspecting regulatory authorities.
- Consultation and support of the importation into the territory of the country of working standards and samples of medicines, medical devices and medical equipments in order to register medicines, medical devices and medical equipments in the territory of Turkmenistan.
Language translations of pharmaceutical documents:
- Language translation into the Turkmen, English and Russian languages of mock-ups, instructions of medical products and other necessary documentation of pharmaceutical companies.
- The company provides these services in a complex of consulting and registration services, as well based on the individual characteristics of your organization.