Regulatory Affairs

Regulatory strategy and EU legislation to compile or finish your dossier

We offer strategic guidance on EU regulatory pathways, helping you navigate complex legislation to support successful product development and compliance.

Regulatory dossier preparation and submission to get your required MA

We assist with preparing and submitting regulatory dossiers for national, MRP, and DCP procedures, ensuring compliance and efficiency.

eCTD registration dossiers

Our experts compile, submit, and maintain electronic Common Technical Document (eCTD) dossiers aligned with the latest regulatory standards.

Compilation of labels, leaflets, and SmPC

We manage the preparation, review, and approval of product labels, patient leaflets, and SmPCs, ensuring regulatory compliance and clarity for users.

Readability testing of Patient Information Leaflets (PIL)

We coordinate readability testing of PILs to confirm they meet regulatory standards and are clear and patient-friendly.

Assessment of registration dossiers to fulfill all requirements to get the dossier approved

Our specialists review registration dossiers thoroughly, identifying gaps and providing clear recommendations for compliance and registration success.

Scientific advice applications

We help you prepare and submit scientific advice applications, strategically guiding interactions with regulatory authorities to enhance your product development.

Change of legal status

We support product classification changes, including prescription to OTC transitions, guiding you efficiently through the required regulatory procedures.

Medical devices under MDR compliance

Our team advises on medical device compliance with the Medical Device Regulation (MDR), including classification, conformity assessments, and technical documentation.

Person Responsible for Regulatory Compliance (PRRC)

We offer the PRRC function within our RA team, enabling external companies to utilize this service to fulfill regulatory obligations under the Medical Device Regulation (MDR) effectively and efficiently.

CE marking for medical devices

We assist with all steps required for CE marking of medical devices, ensuring comprehensive compliance with MDR requirements and EU market access.