Development of normative documents
normative documents, manufacturer's monograph, basic prescribing Information
Most companies come to us, with a complete or almost complete package of documents required to undergo registration procedures in the relevant competent authority. However, in the modern realities an increasingly popular service became the development of the normative documentation on the medicinal product or a pharmaceutical substance.
RusClinic CRO can help to develop normative documentation (ND) or Manufacturer's monograph (MM) for your products, to develop analytical techniques and to validate them in accredited laboratories. We can make the Basic Prescribing Information (BPI) appropriate to all modern requirements, of a medicinal product, based on information about similar preparations (for generics), reports of clinical trials (if any) or organize ourselves clinical studies which are necessary and sufficient for drawing up Basic Prescribing Information.
Our professional designers in close collaboration with you and the experts on registration will develop for you models of primary and secondary packaging for your product, meeting the requirements of the Federal Law of April 12, 2010 № 61-FZ “On circulation of medicinal products”, the article 46, and which guarantees to your product of originality and marketable appeal.