Clinical Regulatory Services

Handling the complexities of clinical investigation approvals can be daunting. Without the necessary expertise, your study may face unnecessary delays or roadblocks.

But that's why we’re here to streamline the process, ensuring you get the green light to start your study efficiently and in full compliance.

What are clinical regulatory services?

Clinical regulatory services encompasses all the approvals and submissions required to initiate and maintain a clinical investigation.

This includes submissions to competent authorities, ethics committees, and other national bodies that are applicable to your study.

Country-specific knowledge is essential to prepare a good submission package and optimize the review process. Compliance with regulations and guidelines such as MDR, GCP, ISO14155, GDPR, and national legislation is crucial for both approval and the successful conduct of your study.

Why is it important?

Under the MDR, stricter requirements and tighter timelines make it crucial to have a thorough understanding of both African and country-specific regulations.

An experienced partner is invaluable for:

Identifying the type of study and involved authorities.
Ensuring compliance with all relevant regulations.
Managing country-specific submission processes.
Avoiding delays by preparing complete and accurate submission packages.
Gaining approval for both applications and modifications or reports during the study’s lifecycle.

Discover how we can help

How can Labmark support you?

We provide tailored support to sponsors and manufacturers, from small startups to large medical device companies.

Our services include:

Submission strategy

Guidance on the best submission route and strategy to align with your goals and timelines.

Submission requirements

Clear documentation of what’s needed, including templates and document support.

Submission preparation

Compilation of complete submission packages, including essential documents like cover letters, powers of attorney, IFUs, GSPR checklists, site suitability, etc.

Submission execution

Direct handling of submissions, including expertise in country-specific portals and processes.

Approval follow-up

Follow-up until approval, assistance with responding to requests for information coming from authorities or ethics committees.

Ongoing support

Amendments, modifications, and reporting throughout the study until the final study report is complete. We also cover other involved bodies that require submission or notification.

Why partner with Labmark?

Our service supports the entire study, from initial approval through reporting and modification submissions, all the way to the final study report.

Here’s how we make the difference:

Strategic insight: we help you with your submission strategy that aligns with realistic timelines and regulatory expectations.
Regulatory expertise: we ensure your submissions are complete, accurate, and adhere to the necessary regulations for approval.
Hands-on support: from initial submission to responses to authorities’ requests, we handle every detail, ensuring your study moves forward without delay.

Which countries have fast approval processes?

The approval timelines vary by country and depend on factors like regulatory pathway, required documentation, fees, and contract processes. We use our country-specific knowledge to advise on the best approach based on your priorities, such as fast review times or low regulatory burden.

What documents are needed for submission?

The core requirements are listed in MDR Annex XV Chapter II, but country-specific documents may be needed. These can include cover letters, power of attorney, GSPR checklist, site suitability forms, and more. Our team ensures all required documents are included and tailored to the specific country and study type.