Regulatory Affairs Support

Scientific Advice

Scientific Advice is a crucial step in the development programme to validate your plans with the regulatory authorities. Scientific Advice, or Protocol Assistance for an orphan product, can be sought from the national regulatory agencies and/or from the EMA. RApport can lead you through the process by:
  • Providing guidance on which Scientific Advice route to take and the optimal timing, including whether to obtain joint advice with Health Technology Assessment Bodies (HTAs);
  • Developing your Briefing Document including questions and company positions;
  • Preparing you for the meeting by understanding and managing any potential issues;
  • Understanding the impact of Scientific Advice to your ongoing work.

Procedure Management

The regulatory processes in Europe can be a complicated maze and navigating the most appropriate route and legal basis for your product and company is crucial. RApport can guide you by:
  • Advising on the procedural route and the legal basis options for your application;
  • Understanding the implications for each option including life cycle maintenance and commercial factors;
  • Preparing and managing the submission procedure for you;
  • Supporting any interactions with regulatory agencies throughout the procedure

Redaction

Managing the public disclosure of your information is becoming increasingly important since the publication of EMA Policy 70 requiring the public disclosure of clinical data from applications submitted after January 1st 2015, including variations, and referenced data previously submitted. The Sponsor can request redaction of any commercially confidential information (CCI) and any documents must be anonymised to prevent disclosure of patient's protected personal data (PPD).

RApport can support your redaction requirements by:

  • Providing guidance on the policy and its implications.
  • Supporting the development of your redaction strategy.
  • Conducting the redaction of the clinical package including drafting the Justification Table and the PPD Anonymisation Report;
  • Supporting your interactions with the EMA.

Life Cycle Management

Managing your product through its life cycle is as important as obtaining the initial approval. Not only is it a regulatory requirement to keep your product up-to-date but it may also help the commercial success of the product. Manufacturing or packaging changes, product information updates and changes in guidelines or legislation often lead to variations being required. In addition, renewals, line extensions to broaden the product range or licence transfers may need to be planned into a product’s lifecycle.

RApport can support you through the whole array of life cycle management by:

  • Assessing manufacturing and labelling changes and developing the life cycle management strategy;
  • Preparing and managing the submission of variations, renewals or other post authorization packages;
  • Reviewing registered and manufacturing details to ensure compliance.

Paediatric Investigational Plans

For new medicines in Europe, there is a legal requirement for a PIP to be in place prior to submitting a licence application. This can be a significant undertaking at a time when companies are often busy conducting studies in an adult population. RApport can offer support and are highly experienced in managing the whole PIP process from:
  • Developing your PIP application and assisting with pre-submission meetings with EMA;
  • To managing the PIP submission through to decision and beyond, including PIP modifications and compliance checks.

OTC's

A key milestone in managing a product's lifecycle is the possibility of being made available without prescription (Over the Counter). Wider healthcare access and increasing costs means the availability of non-prescription medicines is increasingly important to self-manage non-serious health conditions. RApport's hands on experience of managing switches across multiple countries, will be invaluable given the challenges faced by different regulatory and healthcare environments. RApport can guide you through all aspects of a switch application by:
  • Evaluating the feasibility of potential switch products and markets;
  • Supporting your interactions with regulatory agencies;
  • Preparing and managing a switch submission through to approval including any oral hearings.

PIL User Testing

Patient Information Leaflets (PILs) are required for all medicinal products in Europe and must be tested to establish readability. RApport has run user tests since they became mandatory in 2005 and operates a standard process in line with European guidelines. With our experience RApport can guide you through the process by:

  • Advising on the layout and wording of your PIL or drafting the PIL from your SmPC. We can also arrange the artwork and design of the PIL if required.
  • Providing a submission ready report including the information required by the European Regulatory Agencies.
  • If required, we can also provide bridging reports which can sometimes be used instead of a full User Test.