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Registration of Medicinal Products

Company BROKBRIDGE offers services in the field of registration of medicinal products, active pharmaceutical ingredient (API), dietary supplement and also conformity assessment to Technical regulations of medical devices.

 

About Company BROKBRIDGE:

One more direction of company BROKBRIDGE is consulting service in pharmaceutical sphere, namely to provide the widest possible range of services for Ukrainian and foreign manufacturers of medicinal products, API (active pharmaceutical ingredient, substance), dietary supplements, etc.

Well-run cooperation with State authorities (Ministry of Health, SEC (State expert center), State Inspectorate), as well as authorized certification bodies of medical devices and the knowledge of all the nuances of registration/re-registration/certification, allows us to guarantee our customers maximum efficiency of all procedures stipulated by the legislation and, as a consequence, early presentation on the market.

We also offer logistics services and develop effective advertising strategy after the official introduction of the drug, medical devices on the Ukrainian market.

Our services:

  • Advisory assistance on questions of registration, re-registration and amendments to the existing documents, etc.
  • Assist in the preparation and formation of the registration form, micro dossier, registration dossier, including the development of the MQC (methods of quality control), instructions for medical use and labeling of packages.
  • Undergo certification procedure according to technical regulations
  • Obtaining a permit for a one-time import of unregistered medicines.
  • Representation of your interests in the relevant State bodies / laboratories.

Operation concept with clients:

Registration of medicines:
  1. Signing of the Confidentiality Agreement, based on which we make the initial assessment of the dossier provided by you. Then we make comments about missing documents, sections or licenses, articles, etc.
  2. After reviewing of the dossier we evaluate price of the order, calculate the volume of forthcoming works, costs required for the registration of medicinal product, excluding government payments (the Applicant shall pay its own).
  3. Conclusion of the Agreement for rendering of services (between the Applicant and the company BROKBRIDGE). This contract will include all the necessary and important points for both sides - from the performance time to receipt of registration certificate by the applicant.
  4. Holding correspondence, sending requests for the necessary documents, etc. our company will conduct directly with the Applicant / Manufacturer or through a Representative office.
  5. Process of registration / re-registration basically will depend directly on the quality of dossier’s materials, fast providing of the necessary additional documents and answers from the Manufacturer for experts remarks in SEC etc.
Conformity assessment of medical devices to Technical regulation:
  1. Signing of the Confidentiality Agreement.
  2. Conclusion of the Agreement for rendering of services.
  3. Provide consultation on the requirements of technical regulations, list of required documents, checking documents prior to submission to the authorized body.
  4. Translation of the necessary documents, including its legal notarization.
  5. Preparation and signing of the Power of Attorney on representation of interest by BROKBRIDGE on behalf of the Customer in all authorized bodies and to negotiate, pass documents, receipt of remarks etc.