PRODUCT REGISTRATION IN THE EUROPE

Wogen Pharm® is trusted by clients because of its knowledge of European registration strategies, resources to create excellent registration dossiers through our multidisciplinary regulatory affairs, scientific writing, and publishing teams, and management of the submission process from start to finish. We provide a tailored service package to address the unique requirements of the application because each project and customer circumstance is different. The International Conference on Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use (ICH) gives priority to certain regions, which frequently receive first registration priority and make for appealing starting points for global documentation with optimized and harmonised requirements. The majority of our customers seeking initial registrations look for assistance with the EU Generic or Well established used Marketing Authorization Application (MAA). From module construction through markup preparation, publishing, and direct submission to agencies, our teams offer a comprehensive solution. It’s time to collaborate with Wogen Pharm®

It is essential to get in contact with Wogen Pharm® as soon as possible to guarantee a clear understanding of the regulatory pathway because the Food Veterinary Service (PVD) and the European Medicines Agency (EMA) have released various guidance documents on the submissions themselves. Additionally, dynamic registration criteria are now being implemented in the target region. Before a new application can even be considered in the EU, a number of procedures must be completed, therefore it is critical to understand fully the risks and mitigating organized activities with the submission process itself and to organize it against specified milestones. The initial registration file preparation and submission are only the first stage of this procedure.

Registration of EU Products:

Additionally, the EU offers accelerated assessment, i.e., a shorter review period for MAA applications, for pharmaceuticals of significant public health significance, particularly from the perspective of therapeutic innovation Additionally, conditional marketing authorizations may be issued based on applications that may have missing data.
To improve support for the development of pharmaceuticals that address healthcare problems, the EU PRIME (PRIority MEdicines) facility is available. PRIME is a voluntary program that calls for greater contact and communication with the creators of potential pharmaceuticals in order to streamline development schedules and accelerate evaluation so that these pharmaceuticals can be given to patients faster. Regardless of the fact that PRIME is intended to facilitate quick assessment, it will also assist businesses in utilizing EMA’s other early access routes and additional advisory support while still meeting the requirements for the centralized approach.

Services for registering new products:

We at Wogen Pharm® are just as passionate about helping patients by creating new products (pharmaceuticals, cutting-edge therapies, or medical devices). Our consultants have a similar background to those of our clients, so they are aware of the difficulties that must be overcome. As a result, collaboration between consultants and client stakeholders during such projects is unique, and the distinction between client and service provider is dissolved.

Clients depend on our regulatory knowledge, as well as the experience and competence of our experts, to ensure project success. A thorough project plan from Wogen Pharm® can help you with everything from registration strategy to authorization and beyond.

Among some of the solutions we provide are:

  • Registration, centralised (CP), decentralised (DCP), mutual recognition (MRP) and national submissions in Europe;
  • Electronic Common Technical Document (eCTD), publishing;
  • Compilation of Module 1 documents including development of Summary of Product Characteristics (SmPC), risk management plan and environmental risk assessment
  • National requirements for local submission, including advice on the future redaction of full dossiers for international registrations
  • Preparation of labelling including SmPC, Patient Information Leaflets (PIL), Package Inserts (PI) and Structured Product Labelling (SPL)
  • Product name applications
  • Full integration of our consultants within global project
  • Advice on registration strategy: legal basis and selection of registration route.