MEDREG company services

MEDREG company services include conducting procedure registration (re-registration) to medicinal products, registration of the bioactive supplements and also registration of products veterinary. We are the highly qualified team of the professionals, which will accompany the process of the registration from the very beginning and till the time You get the Certificate. Our staff posesses long experience in this area, which provides high quality of the dossier preparation, allows to speed up the process of getting the Certificate, and also helps to positively solve all questions with the State Expert Center of the Ministry of Health of Ukraine (http://www.pharma-center.kiev.ua/view/en/index).

Registration of medicinal products in Ukraine can become expensive and time-consuming process for the companies, which plan to enter Ukrainian market. It is necessary to have a team of qualified specialists during the process of preparation of the documents for the successful completion of the registration. Support of this additional staff increases administrative expenses, but does not guarantee success of the procedure when qualification of the employees will be insufficiently high.

Commit this work to professionals!

Our team is aware of all the details of the procedure of registration of medicinal products in Ukraine, has a profound experience in this area and experience of close practical cooperation with regulatory institutes in Ukraine.

Outsourcing is especially useful for manufactures that only planning to discover Ukrainian market for their products. These companies do not have a representative office or a sufficient staff. Process of the registration it is a process of high responsibility that require great care, thorough knowledge of the requirements of the Ukrainian regulatory institutions. It is extremely hard for the foreign manufacturer to prepare registration dossier (document package) meeting the requirements of the Ukrainian law, to translate it into Ukrainian, to control and to speed up process of the registration from abroad and solve arising questions.

Our professionals will shift this work from You with pleasure!

Our success in registration relies on a few key advantages:

Professional team.

Our registration team possesses enormous experience in registration of different medicinal products.

Fast track with registration authorities.

As our dossiers are perfectly prepared, they quickly move through regulatory bodies. We rapidly receive referrals to laboratory analitical examination and successfully pass it fo evaluation of materials about Introduction of Changes

Result-driven approach.

We are responsible for the end result in all our regulatory assignments. We work as an intermediary between our clients and authorities throughout the course of our projects insuring fast receipt of registration certificates.

Clear and open communication with our clients.

In the course of all our projects we constantly communicate with our clients; they know exactly where in the registration process their drugs are and what are the next steps.

Privacy.

The company observes the principle of Privacy to materials that are provided by our partner.

Our regulatory services portfolio cover all types of work that is of interest to our clients:

Registration of new medicines

Procedure Re-Regidtration

Approval of new or dosage forms

Approval of new routes of administration

Approval of changes of excipients

Approval of variations and administrative changes

 
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