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Regulatory support and Management

Stay informed and collaborate:

Our dedicated Regulatory team continuously monitors industry updates, guidelines, and standards to ensure we remain at the forefront of regulatory changes that may impact our clients' operations.

Our regulatory team tailors its services to meet your specific needs, providing assistance in the preparation of Investigational Medicinal Product (IMP) and Investigational New Drug (IND) dossiers for Clinical Trial Applications.

We can guide you through the entire process, including supporting Q&A sessions with health authorities to ensure prompt and adaptive responses to their inquiries.

Our scope of work:

Preparation of briefing books

Dedicated to pre-submission meetings. 

Comprehensive support in IMPD and IND writing, review or update

Providing technical, quality and Module 3 dossier preparation for clinical trial applications.

Navigating the regulatory landscape

Support of development teams 

Identify key issues and participate in regulatory discussions, facilitating Scientific Advice in Europe or Pre-IND meetings with the FDA in the US.

Advise, prepare, and represent clients at health authority meetings

Providing technical support to clients with in-house labs, offering guidance on upstream and downstream processes.

In Europe, the US and regions such as the UK, adapting to changing guidelines and harmonizing responses across different regulatory bodies.

For inquiries or to explore how our services can benefit your specific regulatory needs, please contact us

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