P2F Ventures Limited can offer a fully integrated or bespoke consultancy service, tailored to your company’s own needs and capabilities. We can support you through the whole product development process (from in-vitro research through to regulatory submissions) or target specific developmental challenges such as the conduct of the critical clinical trials (human intervention studies) or the regulatory dossier submissions process.
1. Assessment of existing data packages
New clients of P2F Ventures Ltd will often ask us to begin by reviewing the existing research data on a product in order to evaluate their chances of success, whether the target health claim(s) are achievable, and in what timeframe and application can be prepared.
This step can really help to identify any specific challenges the company may face in a particular health claims area and strengthen ongoing work programs.
The previous scientific opinions issued by EFSA’s NDA Panel are a valuable but under-utilized resource to all future health claim applicants and so we closely monitor these past applications in order to advise a client on potential barriers to success. This can really help to avoid potentially costly mistakes later in the application process.
2. Project Planning
Successful projects are usually built on a well-considered project plan. Using our knowledge and first-hand experience of the development/regulatory processes needed to secure a health claim, we can help to evaluate/validate your own internal project timelines. Alternatively we can construct integrated project plans to guide your project.
The core of P2F Ventures Limited’s consultancy is to advise on the design and implementation of the necessary development activities required to achieve health claims. This includes the critical human intervention studies which are the main focus of the regulators and which ultimately determine the conditions of use. These clinical studies remain pivotal to success or failure in the functional food space.
Our background in conducting clinical development programs to Good Clinical Practice (GCP) standards in the pharmaceutical industry means that we can help design, cost and implement the necessary studies to the quality standards needed in this sector. We are able to advising on suitable facilities to conduct the studies and offer QA and reporting services (using in-house templates for key documentation).
We can support you to compile the necessary data into a health claims dossier using past successful applications as a template. We also offer stewardship through the review process in order to help address the questions that may come back during review and prevent unnecessary clock-stops during the review process.