Regulatory plan and compliance review

Unlock your product’s potential in the global market.

Understanding the intricate landscape of global regulatory frameworks is crucial for ensuring your product not only meets safety evaluations but also surpasses them.

At Biosafe, we specialise in navigating these complex waters, providing you with an exhaustive Regulatory Plan and Compliance Review that positions your product for success across different markets, including the EU and the US.

Regulatory status assessment


Navigating the complexities of regulatory frameworks can be daunting. Our service begins with a thorough assessment of your product’s regulatory status, answering pivotal questions such as:

  • Which permits are necessary for your product’s launch?
  • Under what category does your product fall, and what specific regulations apply?
  • Identification of all relevant regulations and guidance documents that influence your product’s market entry strategy.
  • Evaluation of various market access options, analyzing both requirements and timelines to pinpoint the most viable paths for your product.

Crafting your regulatory roadmap

With a clear understanding of your product’s regulatory standing, we proceed to develop a comprehensive regulatory plan. This includes:

  • A detailed excel table or roadmap, serving as a blueprint that outlines all requirements and timelines specific to your product.
  • This strategic plan is designed to guide you through the entire regulatory process, ensuring you know exactly what steps to take and when to take them.

Gap analysis integration

Following the establishment of your product’s status and regulatory plan, a gap analysis is typically the next step. This crucial phase is where we:

  • Identify any discrepancies between your current data and the regulatory requirements.
  • Develop a tailored plan to address these gaps, specifying what additional information or studies are needed.
  • Please note, while a gap analysis is an essential tool in the regulatory process, it is most effective when conducted after the initial status and plan are clearly defined.


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