Product Management

The regulatory processes in US, Europe, Japan, China, Canada, Australia are a complicated maze and taking the most appropriate route for your product and company is crucial. Even when you have decided on the route it is challenging to navigate your way through to the end.

This is where RApport can guide you. RApport are highly experienced in:

  • Advising on the options for the legal basis for your application;

  • Evaluating the procedure options for your product both in terms of the options available and the pros and cons of each option;

  • National applications including updating to ensure they are ‘mutual recognition’ ready;

  • Mutual recognition applications launched from an already approved national licence into further member states;

  • Decentralised applications which are submitted simultaneously in ≥2 member states;

  • Centralised applications submitted to the EMA and mandatory for certain types of product;

  • Understanding the implications for each option including life cycle maintenance and commercial factors;

Product Life Cycle Management (Global)

The pharmaceutical, biotechnology and medical device industries are among the most highly regulated industries in the world. Regulations are applied to all products from those that are new and innovative to those that are long established.

Managing a product throughout its life cycle is as important as getting through the initial approval. Not only is it a regulatory requirement to keep your product up-to-date and to remain compliant but it may also help the commercial success of the product.  

We can support your product life cycle management through the following phases:

  • International business expansion;  help with entering the global market place

  • New product development; formulation and Country regulatory feasibility surveys 

  • Manufacturing / Production; tech transfers, quality assurance, special manufacturing requirements

  • Mutual recognition applications launched from an already approved national licence into further member states;

  • Common technical document compilation; Modules 1-5 in ICH regions and beyond

  • Submission to regulatory agencies and notified bodies; National, DCP, MRP, Centralised

  • Approvals/ MA; project management, harmonisation activities 

  • Post approval Variations and Renewals

PIL User Testing and OTC’s
Publishing and Redaction