Registration of medicines and medical devices is a pre-requisite for commercial activity in a given country. Fast and proper registration saves time and money for manufacturers allowing for quick launch of sales.

Raifarm has an outstanding experience in drug registration and other regulatory work; over the past three years we successfully completed in excess of 130 individual projects – more than all other agencies in Russia combined! We registered more than 50 new products for leading international pharmaceutical and biotechnological companies, with many of them being revolutionary orphan and complex biologics drugs.

According to Association of International Pharmaceutical Manufacturers, the average time-to-registration in Russia is over 30 months. Raifarm can facilitate product registration in record times, frequently in less than 10 months; our regulatory work is also characterized by the highest quality.

Our success in registration relies on a few key advantages:

• Professional team. Our registration team possesses enormous experience in registration of different drugs and medical devises. It includes professional chemists, analysts, medical doctors and biologists. Their deep professional knowledge combined with detailed understanding of all existing procedures and regulations allows us to prepare flawless registration dossiers that are in exact accordance with requirements of regulatory bodies

• Fast track with registration authorities. As our dossiers are perfectly prepared, they quickly move through regulatory bodies. We rapidly receive referrals to laboratory pharmaceutical examination and successfully pass it

• No “down time”. Often authorities request additional information or require clarification on documents already submitted. These requests take long time to process and can significantly slow down drug registration. Raifarm uses proactive approach; we communicate daily with regulatory bodies and constantly track progress of our submissions. If some additional data is requested, we immediately know about it and are able to quickly provide required documents without any interruption in the registration process

• 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. While we solve the vast majority of registration challenges ourselves, we always inform our clients of any developments with their drugs in registration

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

• Registration of new medicines and medical devises

• Completion of pending submissions

• Renewal of registrations

• Approval of new pharmaceutical and/or dosage forms

• Approval of new routes of administration

• Approval of changes of excipients

• Approval of variations and administrative changes

• Post-approval regulatory and pharmacovigilance support