Regulatory Affairs regulations are in the centre of any pharmaceutical business development plan, however the complexity of Marketing Authorizations for various territories can become a serious obstacle in achieving business objectives.
Through our experience with Regulatory Affairs management of both European Union regulations as well as other, local pharmaceutical markets in Africa, Asia, Central and Eastern Europe we can assist in drawing the appropriate regulatory strategy and provide knowledgeable assistance in pharmaceutical registrations and associated activities.
The key services include:
Advising on local Regulatory Affairs regulations
Over 10 years’ experience in the field of Regulatory Affairs, make us a qualified advisor when it comes to diverse, local pharmaceutical regulations. Our global presence in the pharmaceutical markets endorses our know-how in the management and execution of Regulatory Affairs regulations.
Recommending appropriate regulatory strategy
The registration procedures of pharmaceutical products and devices can be disheartening when faced with the complexity of required regulations. Owing to our expertise in Regulatory Affairs regulations of European Union pharmaceutical market, as well as other, local pharmaceutical markets in Africa and Asia we provide counseling on local Regulatory Affairs regulations and recommend the appropriate regulatory strategy for your business.
Dossiers recommendations and review
J&P Pharma can provide expert advice on preparation and review of dossiers for submission and registration of pharmaceuticals, generics, food supplements and medical devices. Our independent and strategic guidance assures successful dossier submission in a timely manner. We are also knowledgeable in European Union pharmaceutical CTD dossier delivery.
Products registration service
Pharmaceutical products registration requires sound knowledge of Regulatory Affairs and complex regulations required for the process of registering medicines, generics, food supplements and medical devices. At J&P Pharma, we have the necessary understanding of the Regulatory Affairs and management capabilities required for providing European Union pharmaceutical products to your market.
Monitoring and liaising with the local Regulatory Agencies
At J&P Pharma we keep abreast of local Regulatory Affairs regulations laison with local Medical, Drug or Regulatory Agencies, or Ministry of Health Departmensts resposnible for MA procedures an effortless endeavor. We can assume the process from “a to z” or just partially, monitoring your liaising procedure.
Licences and certificates transfer
Our advisory know-how also includes pharmaceutical licensing. We will assit you in evaluating licensing opportunities for licence in or Marketing Authorisation transfer that are in the center of your pharmaceutical business development plan.