EarlyHealth Group prides itself on offering comprehensive Quality Person (QP) and Regulatory services tailored to sponsors’ clinical research across all trial phases.
Navigating the regulatory landscape is crucial to the success of the study, and our experience ensures that the challenges of global audits through to the release of clinical trial materials are seamless, monitored, and compliant. Our team of qualified professionals oversees every stage of the process, ensuring patient safety by auditing the supply chain for GMP compliance and certifying products for use in clinical trials.
Our QPs also provide consultancy services to ensure that operations comply with all relevant EU directives and necessary regulations.
OUR SERVICES
- Regulatory Compliance Audit Services for clinical trial service providers and contract manufacturers
- QP Certification and Batch Release
- Regulatory Strategy Development
- Preparation and Submission of Regulatory Documents
- Clinical Trial Application (CTA) Submissions
- Marketing Authorization Application (MAA) Preparation
- Pharmacovigilance and Safety Reporting
22
Qualified Persons in service
18
of 20 Big Pharma Use Our QPs
+100
Trials Managed
20K
flawless batches released
WHY CHOOSE US
Expertise Across
Phases
From Phase 1 exploratory trials to Phase 3 pivotal studies, we offer specialized services that align with your evolving regulatory needs at every stage of clinical development. Our deep understanding of clinical protocols ensures efficiency and compliance throughout the process. Partner with us to navigate each phase with precision and confidence.
Trusted
QP Services
Our team of Qualified Persons (QPs) provides invaluable guidance and oversight, ensuring that your investigational medicinal products (IMPs) meet the highest quality standards and regulatory requirements. We are committed to maintaining the integrity of your products from production to patient. Trust our QPs to uphold the rigorous standards required for successful clinical trials.
Comprehensive
Regulatory Support
Navigate the complex landscape of regulatory affairs with confidence. We offer strategic regulatory consulting, dossier compilation, submission support, and ongoing compliance monitoring to keep your projects on track. Our proactive approach minimizes risks and accelerates approval timelines. Let us help you achieve regulatory success efficiently.
Tailored
Solutions
We understand that each project is unique. Our flexible approach allows us to tailor our services to fit your specific goals, timelines, and budgetary considerations. Whether you need comprehensive support or targeted assistance, we adapt to meet your needs. Experience customized solutions designed to drive your project forward.
Global
Reach
With a network of experts and partners worldwide, we offer seamless support for multinational clinical trials, helping you overcome regulatory hurdles and expand your reach into new markets. Our global presence ensures that you have access to local expertise and resources wherever your trials take place. Expand your horizons with our extensive international network.
Send Us An Enquiry
To learn more about how we can improve your QP and regulatory services experience or receive a quote, please feel free to get in touch.