Expert support for seamless submissions and successful approvals

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Regulatory Services

Regulatory Affairs at Alcedis ensures that studies start and finish on solid legal ground. Our team manages all regulatory interactions from initial document collection to ethics approval, authority notifications, and amendments. With deep knowledge of European and national regulatory frameworks, we streamline submission processes and ensure compliance at every stage of your clinical project.

  • Collection and compilation of submission documents
  • Initial submissions to ethics committees
  • Preparation and submission of substantial and non-substantial amendments
  • Notifications to national competent authorities
  • Submission of study end declarations
  • Coordination with legal representatives and local ethics bodies
  • Compliance with EU CTR, national law, and ICH-GCP
Expertise

Experienced regulatory specialists navigate ethics and authority landscapes with confidence—national and EU-wide.

Compliance

From initial approval through final close-out, we manage all updates, amendments, and reporting requirements.

Streamlined

Efficient document collection, formatting, and submission workflows reduce delays and administrative burden.

Coordination

Close coordination with project managers and medical writers ensures consistency, traceability, and smooth execution.

Regulations evolve

- so do we.

Regulatory requirements are complex, time-sensitive, and differ between regions. Here’s how we help our clients stay ahead:

  • Up-to-Date Expertise: We continuously track evolving regulations (e.g., EU CTR) to ensure submissions are compliant with the latest standards.
  • Amendment Management: Whether driven by protocol updates, safety findings, or operational needs—we coordinate and submit amendments quickly and correctly.
  • Complete Study Close-Out: We guide the final regulatory steps, including authority notifications and declarations of the end of the study—ensuring nothing is left open.

Smooth Start-Up through Clear Regulatory Planning

  • Early regulatory clarity is key to avoiding delays. At Alcedis, we prepare and submit complete, audit-ready application packages to ethics committees and authorities—ensuring accuracy, completeness, and strategic timing.
  • We manage local ethics interactions and liaise with legal representatives when needed, providing sponsors with peace of mind and full oversight.

"We are collaborating with Alcedis for many years in several indications and as such in some local oncology studies. I believe one of the success factors for Alcedis is their high commitment and the hard work they bring into assigned projects. Besides great expertise in clinical research, another sweet spot is definitely their IT solutions for innovative data capture in clinical studies."

Dr. Lars Mühlenhoff
AstraZeneca, Director Medical Affairs Oncology

"In our collaboration I experience Alcedis as a very cooperative and flexible partner. The internal organisation is very good, which one can see for example in the harmonous and efficient communication between the departments involved. Tasks were always done punctually and in good quality. The project-team was always very open during the creation-process and supported us with good advice, based on the past experience. I am very happy to be working with such an experienced and well-tuned CRO-team. The cooperation is really fun and I would definitively recommend Alcedis!"

Dr. Susanne Oesch
Bayer, Medical Advisor

"I have made very good experiences with Alcedis in several global projects over the last years. I recommend their professionalism and hands-on mentality as a full service CRO with excellent eCRF solutions. Working with such a dedicated team was joyful on top and I can fully acknowledge Alcedis as a trusted partner!"

Alexey Medvedchikov
Boehringer Ingelheim, Regional Medical Affairs Operations

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