Dossier services
New ingredients, pet foods, heath claims or specific products (food supplements/natural mineral water) can require approval or registration by regulatory authorities before market launch. Let Leatherhead Food Research be your trusted partner and guide you through the registration process. Our dossier services cover Novel Foods (EU), GRAS (USA), PARNUT (pet foods in the EU), food supplements and natural mineral water.
The rapid evolution of consumer demand and technological capability are driving innovation at a pace that is stretching the limits of regulation. Across markets worldwide, an increasing number of products are requiring formal approval as ‘novel’ products, processes or technologies. Leatherhead’s dossier services provide an end-to-end solution, guiding clients throughout the process. Our services encompass qualification, preparation and submission of dossiers for human and pet foods. We also work closely with the regulatory authorities post submission, handling questions on our clients’ behalf.
Leatherhead’s regulatory experts and scientists are here to help
- Scope the time, resources and investment needed to develop a dossier ready for submission
- Perform a gap analysis on your dossier to highlight missing information
- Compile and submit your dossier
- Take the pressure off your team by handling any questions raised by the authorities on your dossier
Dossier services
Novel food and new ingredient dossier service →
Health claims dossier service →
Pre-registration service
Did you know?
The following may need pre-market approval or registration before marketing in the EU, Great Britain or the USA:
- Novel/GRAS ingredients
- Food additives
- Food enzymes
- Food supplements
- Natural mineral water
Why Leatherhead?
Upfront qualification: We’ll work with you to qualify your investment upfront and the likelihood of success.
You’re in safe hands: Leatherhead’s experienced technical experts, including ex-regulators, help clients navigate regulations, worldwide.
Regulatory relationships: Our strong relationships with key regulatory bodies provide insight into how to manage dossier submissions and handle queries after submission.
You’re in control: All our dossier projects are structured with clear stage-gates and decision points so you’re in control of project progression.
Collaborative: Our experienced, multi-lingual regulatory experts work closely with your key stakeholders, ensuring our recommendations are aligned to your organisational objectives.
Multi-national: Leatherhead’s dossier services span Great Britain, the EU & US. We provide regulatory advice for over 100 key countries.
