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:
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:
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
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
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.