Contractual manufacturing of active pharmaceutical ingredients and biological substances

Pepeliaev Group’s lawyers have provided legal support to a client within the framework of organising the contractual manufacturing of active pharmaceutical ingredients and biological substances jointly with a Russian pharmaceutical company. Our experts devised Russian-law agreements on the contractual manufacturing of active pharmaceutical ingredients and biological substances; settled all the issues relating to the registration of such substances in Russia; and clarified to the client the situation with the serial manufacturing being introduced in our country. In addition, they filed the relevant patent application and settled the issues relating to VAT being collected when biological substances are sold.