Registration
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Registering products with local regulatory bodies is a pre-requisite for sales-related activity. It is one of the most difficult and time-consuming processes for a pharmaceutical company wishing to operate in emerging markets. According to the Association of International Pharmaceutical Manufacturers, the average time-to-registration in Russia is over 2 ½ years. Raifarm can facilitate product registration in record time, frequently within 10 months. As our clients well know, a day less of registration means a day more of sales. Outsourcing registration to Raifarm means substantial savings in management time and attention. Raifarm’s provision of auxiliary services – from dossier preparation for Ministries of Health to handling of Customs Import Permits – results in additional savings for our clients. Why are we so successful in registering pharmaceuticals in emerging markets? We have a focused strategy and a talented, dedicated staff. We do it right the first time and we commit significant resources to the registration process. Without guidance, companies can fail to complete the dossier in a precisely, required way, and must therefore go back-and-forth with regulatory bodies to clarify all issues. This takes up valuable time. We know the demands of regulatory bodies, and we ensure that the dossier is prepared in accordance with all guidelines. Frequently, we involve outside experts to assure that documents are in precisely the right format and that all questions are answered. If additional information is required, we learn that early on, and ask our clients for the missing data immediately. Similarly, we continuously monitor the progress of the submission when it is within the regulatory bodies. Thus, we ensure that the documents are not lost and are able to move quickly through the required procedures. We have a superbly qualified team. They have decades of first-hand experience with the relevant regulatory bodies. They know both the processes and the people very well. They leverage extensive knowledge and contacts, and they achieve rapid registrations for our clients. We are so effective in successfully managing the pharmaceutical registration process that our work was recently covered by Bloomberg, Reuters, Associated Press, and other news agencies. |





