QP & Regulatory Services

Ensuring regulatory compliance and streamline your journey from early development to successful market authorization.

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.


  • 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


Qualified Persons in service


of 20 Big Pharma Use Our QPs


Trials Managed


flawless batches released


Expertise Across

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.

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.

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.


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.


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.