Regulatory plan and compliance review

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:

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

With a clear understanding of your product’s identity and properties, 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 authorisation process, ensuring you know exactly what steps to take and when to take them.

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.