Novel foods consulting

undefined

Navigating the complex landscape of novel foods regulations can be a daunting task. At Biosafe, our novel foods consulting service offers comprehensive support to ensure your novel food products meet the necessary regulatory requirements for approval and market access.

Evaluation of Novel Food Status:
Determining whether your food product falls under the category of novel food is the crucial first step. Our experienced consultants will conduct a thorough evaluation, considering factors such as production methods, ingredients, and historical consumption, to assess if your product qualifies as novel according to the regulatory definitions. This initial evaluation provides an understanding of the regulatory pathway your product needs to follow.

Novel Food Application Process:
Once the novel food status is established, our consultants will guide you through the entire application process, ensuring all necessary steps are taken to meet regulatory requirements.

Our services include:

Regulatory Framework Assessment: We identify and analyze the relevant regulations, guidelines, and guidance documents applicable to your novel food product. This comprehensive evaluation sets the foundation for a successful application.
Gap Analysis and Compliance Review: Our experts conduct a detailed gap analysis of your product to identify any areas that may require further data generation or adjustments to meet regulatory standards. This review ensures that your dossier is complete, compliant, and ready for submission.
Study plan review: We meticulously review your study plans and data to ensure they align with regulatory compliance guidelines. Our team offers valuable insights and recommendations to optimize your data package and enhance the chances of a successful evaluation.
Market access strategy: We assist you in formulating a strategic market access plan, considering the regulatory requirements and timing for different markets. This strategic approach helps you navigate complex market landscapes and seize growth opportunities.
Tailored analytical services: Our consulting services can be customized to address your specific needs, such as conducting specialized analyses or providing scientific support for your novel food application.

Take the next step towards novel food approval and market access. Request a quote or get in touch with our experts to discuss how we can help you navigate the regulatory landscape and bring your innovative food products to market.