Regulatory Compliance

We provide up-to-date regulatory advice and document management solutions for successful trial outcomes.

Ensuring Trial Success and Compliance

Streamline Clinical Trial Packaging and Labeling with Expert Regulatory Guidance

At ICS, we understand the complexities and ever-changing nature of regulatory requirements for clinical trial packaging and labeling. Our goal is to simplify the process for you, ensuring compliance with the FDA, EMA, MHRA, GMP, GCP, and ICH regulations. By leveraging our control tower technology and up-to-date third-party guidance, we provide comprehensive solutions that meet the highest regulatory standards.

What You Can Expect

Achieve Regulatory Compliance and Peace of Mind

Hassle-Free Compliance

Save time and effort by relying on our expertise in navigating complex regulatory landscapes. We handle the intricate details of packaging and labeling compliance, so you can focus on advancing your clinical trials.

Accurate and Compliant Labeling

With our guidance, your clinical trial packages will feature precise and compliant labeling information. Our up-to-date regulatory knowledge guarantees accuracy and adherence to country-specific requirements.

in Regulatory Practices

Gain peace of mind knowing that your importation processes and packaging designs align with regulatory guidelines. Our meticulous approach minimizes risks, delays, and potential regulatory issues.

Our Services:

Regulatory Guidance for Compliant Clinical Trials

Ensure your Clinical Trial Packaging / Labeling is Compliant with Respective Country Regulations (FDA, EMA, MHRA, GMP, GCP, ICH)

ICS uses control tower and 3rd party regulatory guidance for up-to-date accuracy in label preparation, importation requirements and primary/secondary packaging designs.

Core Document Requirements

ICS specializes in lead time management of documents required for Qualified Person release and Heath Authority Submissions.

InteraCTive Clinical Solutions Has Experience With:

Blinded, Open Label and Long-Term Extensions

Phase I through Phase III

Small Molecule – Biologics – Gene Therapy – I&I/Oncology

Capability to Demand Plan 50-30,000 patient trials



Eastern Europe


United States



Contact us today to explore how our Regulatory Compliance service can optimize your clinical supply chain.