Agency Meetings including Scientific Advice

It is an important part of development to validate your plans with the regulatory authorities and understand their concerns regarding your programme. This can help you mitigate risk in your ongoing development.

We understand Agency requirements, for example EU Scientific Advice (or Protocol Assistance for an orphan disease), FDA Hearings/meetings, Regenerative medicine at PMDA, or other international regulatory agencies.

 We can help you

We can help you to obtain International Agency Advice by:

  • Deciding where and when to obtain Advice, including whether to obtain joint advice with Health Technology Assessment Bodies (HTAs) who will eventually decide the reimbursement of your product;

  • Attendance at Type A, B, and C meetings;
  • Consultations with the PMDA, MHLW;

  • Developing your Briefing Document;

  • Developing the questions to be raised with the Agency and the Company Position;

  • Preparing you for the meeting, understanding potential issues and planning for, managing and follow up of those issues.

  • Understanding the impact of Regulatory Agency advice;

Paediatric Investigational (Study) Plans (PIPs, PSP’s)

For new medicines in Europe, US or global research in paediatrics, there is a legal requirement for a PIP/PSP 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 with this and are highly experienced in managing the whole PIP/PSP process from:

Developing your PIP/PSP application and assisting with pre-submission meetings with EMA, FDA;

To managing the submission with EMA/FDA through to decision and beyond, including PIP modifications and compliance checks prior to submission of your licence application.

Orphan Drugs

“Orphan drugs” are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases or disorders that are rare. The development path for orphan drugs is not always straightforward.

RApport has experience with numerous orphan drug development programmes and can help advise you with the:

Establishment of the orphan drug status of your product;

Preparation and submission of orphan drug designations;

Regulatory strategic support including maintenance of orphan status

Clinical Trial Applications (CTAs, INDs)

A Clinical Trial Application or Investigational New Drug application is a legal requirement before starting a clinical trial on any medicinal product in most countries. Approval must be received from the appropriate national regulatory agency, prior to study start.

RApport has hands-on experience with CTAs’ across the ICH regions with specialists in Europe for all Phases of development in a wide range of products and therapeutic areas.

Guidance and assistance with the preparation of CTA/IND documentation including the review and authoring of core documents e.g. protocol, IMPD and IB;

Identification and preparation of the required country specific documentation for the CTA/IND
submission;

Managing the submission process nationally or through the equivalent VHP, liaising with the regulatory agency to gain approval;

Management of the CTA after approval, from substantial amendments through to the end of trials and submission of the Clinical Study Report

Project Management

At RApport we believe that project management is all about people, not tools. Yes, we use tools to monitor projects but project management is so much more. You may not have enough resource to monitor your project and keep it on track. As regulatory is involved in all aspects of development we are uniquely positioned to provide project management support alongside our regulatory expertise. We have managed projects for numerous companies, using regular meetings, status reports and our experience to keep the project on track and all the balls in the air. We can become part of your team and offer as little or as much support as you need.