Why Choose Guires's FRL as Your Food Product Development (FPD) Consultant and Partner?

There are several options in almost every product area in today’s market, and the difficulty is in coming up with unique items that stand out and connect with customers. Guires Food Research Lab (FRL) takes a holistic approach to creating food and beverage products. We define, demographically target, and build effective goods through a sequential process for category selection and comprehension. The client can visit the lab to learn the process. We offer unlimited rounds of revisions to ensure customer satisfaction. The final product prototype, along with the documentation process, including the video (through email), will be shipped to the client, and in case the client is not satisfied with the video, a food technology consultant will visit the place for the product demo at the client’s costs.

What are the different forms that you deliver the Food Product Formulations?

The food industry is witnessing a new form of consumption. Keeping that in mind, we can formulate the products in the form of ready-to-eat, ready-to-drink, ready-to-mix, ready-to-serve, and ready-to-cook food products. We use ingredients that offer an added value to the development and improve its indulgence and sustainability in terms of its functional ingredients, plant-based food dyes, and natural preservatives with a clean label.

What are the sectors Food Research Lab cover?

We cover a wide range of sectors such as soups, sauces and dips, chips, tortillas, dry beverage powder, plant-based products, masalas, puddings, instant mixes and many more.

How is sensory testing been carried out?

Our sensory examination leads to the precise formulation and recipe recommendations. We develop data-driven design models based on sensory research and customer insights. The fact-based design methodology used by Guires reduces risk and gives our clients market confidence while cutting development time in half. With our dedicated sensory lab facility, our team takes satisfaction in creating and optimizing successful products in the marketplace, generating a favourable return on investment, and developing brand advocates.

How does Guires FRL global contract R&D assist with dossier preparation for Nutraceuticals?

12 Oct

How does Guires FRL global contract R&D assist with dossier preparation for Nutraceuticals?

by admin

in Blog, Dossier Preparation

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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.

Guires FRL global contract R&D for dossier preparation of nutraceutical products

Guires 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 Guires 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

Guires 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

Guires 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 Guires 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.