How does Food Research Lab(FRL) global contract R&D assist with dossier preparation for Nutraceuticals?
What is a dossier?
- A dossier is a common term used in regulatory affairs, and it refers to a collection of documents that elaborate on the efficacy, quality and safety of the medicinal product.
- Although the dossier was intended for pharmaceutical products and medical devices, its use was extended to include other products that are highly regulated- like nutraceuticals, dietary supplements and cosmeceutical products.
- As part of the regulatory approval procedure, the dossier is submitted to regulatory agencies such as the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA) in Europe. Therefore, dossier preparation is a crucial step for regulatory approval and marketing.
- The particulars and specific requirements of a regulatory dossier can differ based on the type of product and the regulatory body concerned.
What is the purpose of a dossier?
A dossier usually serves the following purposes:
Documentation
- Dossiers help to store and organise papers, data, and information about a product in a systematic and complete manner. This ensures that essential information is readily available when required.
Adherence to regulations
- A dossier is commonly developed in regulatory affairs to fulfil regulatory requirements. Dossiers are submitted to regulatory bodies in pharmaceuticals, medical devices, and other regulated industries, for example, to request approval for a product or establish compliance with the regulations.
Help with Decision-making
- Dossiers offer decision-makers a structured and organised set of information that can help them make informed decisions. In the legal context, for instance, a dossier may be used for preparing a clinical trial or to provide evidence to support a claim.
Registration and approval of a product
- The dossier should include facts and information supporting the safety of the product. This contains information regarding the product’s ingredients, production procedures, and safety studies to make sure that consumers do not face any risks.
Efficacy of a product
- Dossiers may provide evidence to back up the purported health benefits or efficacy of the product. This could include scientific research, clinical trials, or other data demonstrating the product’s usefulness in improving health or managing specific health-related issues.
Post Marketing Surveillance and Reporting
- Dossiers may include strategies for post-market surveillance, monitoring, and reporting of adverse occurrences or issues associated with the product. This is critical for continuing safety assessments and helps prevent product recalls.
Food Research Lab(FRL) global contract R&D for dossier preparation of nutraceutical products
Food Research Lab(FRL) global contract R&D, a unit of Guires Solutions, has expertise that can assist in dossier preparation for nutraceutical products.
Regulatory Guidance
- Experts at Food Research Lab(FRL) global contract R&D are well-versed in the regulatory requirements for nutraceuticals in different parts of the world. The experts can offer guidance on the necessary documentation, testing, and labelling requirements that are required for compliance.
Documentation
- Food Research Lab(FRL) global contract R&D may assist in compiling the essential documentation for the dossier, such as test results, clinical studies, and other pertinent information. The experts can ensure that the dossier is well-organised and complete.
Submission to the Regulatory Authorities
- Food Research Lab(FRL) global contract R&D helps with the actual submission of the dossier to regulatory agencies, as well as providing support throughout the approval process.[1]
Conclusion
A dossier is a collection of papers that outline the safety, efficacy, and quality of highly regulated products such as medicines, medical devices, nutraceuticals, supplements, and cosmeceuticals. Dossiers play a crucial part in providing vital information, assuring regulatory compliance, assisting decision-making, facilitating product registration and approval, confirming product efficacy, and allowing post-marketing surveillance.
How Food Research Lab(FRL) global contract R&D can help
We are a global contract R&D that assists with the development of highly regulated products, such as nutraceuticals, dietary supplements, herbal products and cosmeceuticals.
We assist food, cosmeceutical and nutraceutical companies with dossier preparation, which is crucial for regulatory approval.
- For food products- We offer food product dossier preparation, which provides all the essential information related to the product formulation, composition, product labelling and declarations and plant certifications,
- In the case of cosmeceutical dossier preparation, we offer valuable information related to batch formulation, product specification and clinical trial data.
- For nutraceuticals, we assist nutraceutical companies with meeting regulatory approval from the US, Australia, the EU and the UAE through our nutraceutical dossier preparation.
We help with documenting product information, quality control, safety data, and other crucial details. Our services also include product classification, review, gap analysis, compilation of the necessary documents for registering the products and product certification, thereby enabling market access.