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.
Confidence 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
Canada
EU
Eastern Europe
APAC
United States
LATAM
Australia