Development
Scientific Advice and Agency Meetings
Proactive engagement with EU national authorities and/or the European Medicines Agency (EMA) can significantly improve chances of regulatory success. It is now considered a critical step in development to engage with Regulatory Authorities as early as possible to ensure that time, effort and expertise are invested in a development program that is vetted by the regulators. This could be the determining factor for companies being commercially successful in bringing product to market.
How we support you:
- Determine the best timing to request Scientific Advice on your development programme
- Identify key areas of challenge and topics for discussion with the regulatory authorities
- Prepare all documents including the briefing document
- Effectively coordinate all communications with the regulatory authorities
- Prepare and project manage all aspects of the interaction with the agency, including the scientific discussion meeting
Clinical Trial Authorisations
Before clinical trials can be initiated in human volunteers or patients, the regulatory authority in each EU Member State, where the trial will be conducted, must approve a clinical trial application. Multiple regulatory documents are required, together with an overall risk-benefit assessment, and critical analyses of non-clinical and clinical data.
At Regulatory Specialist, we can co-ordinate and manage all aspects of your clinical development program and help manage the documentation for the whole clinical trial authorisation life-cycle, including preparation of necessary documents required to initiate your study and coordinate correspondence between the regulatory authority and your company.
Paediatric Investigational Plan (PIP)
A Paediatric Investigational plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children. All applications for marketing authorisation for new medicines and new indications that are patent protected have to include the results of studies as described in an agreed PIP. The plan should include all age subsets from 0-18 years. Proposals for PIPs are submitted to the European Medicines Agency Paediatric Committee (PDCO), and the plan must be agreed before a marketing authorisation application for your medicinal product (adult indication) can be validated.
How we support your Paediatric Development:
- Advise on the various rewards and incentives offered by the Paediatric Regulation and other European procedures
- Advise on PIP strategy (paediatric development plan, deferral or waiver)
- Preparing the PIP application
- Project manage the entire PIP application process with the agency
Orphan Drug Destination
The development and authorisation of medicines for life threatening or chronically debilitating condition that are rare are termed ‘orphan medicines’ in the medical world.
Companies developing medicines for these rare diseases can benefit from a number of incentives by applying for Orphan Drug Designation.
How we support your Orphan Drug Designation:
- Provide regulatory advice on the suitability of your product for orphan drug designation
- Coordinate all communications with the European Medicines Agency and regulatory authorities, including representation at relevant meetings
- Prepare and manage all regulatory aspects of your orphan drug designation application
Marketing Authorisation Application
Prior to commercial use in a region or country, a marketing authorisation application in the EU must be submitted to the relevant health authority. This application contains the data that provides the evidence of the suitability of the medicinal product for the intended use relating to its quality, efficacy and safety. The content and format of the marketing authorisation application must be prepared consistent with regulations and guidelines defined by the regulatory authorities and must be submitted in eCTD format.
How we support your Marketing Authorisation Application:
- Help you navigate through all the requirements of regulatory documents
- Coordinate all communications with competent authorities throughout the application process
- Advise on filing strategy to ensure the correct legal basis and most appropriate submission route is used to ensure faster approval
- Review all documentation supplied and advise on any deficiencies or potential issues which may arise during regulatory assessment