Regulatory Services in UK

Regulatory Compliance Experts in UK

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is part of the Department of Health. The MHRA includes the Clinical Practice Research Datalink (CPRD), including the National Health Service (NHS), and the National Institute for Biological Standards and Control (NIBSC) that function synergistically to regulate medicinal products. Additionally, it oversees partner organizations and other agencies to monitor and evaluate medicinal product regulation and promote patient safety. The MHRA works in close accordance with the European Medicines Agency (EMA) however some changes have been implemented post the Brexit transition. MHRA-issued licenses are no longer recognized in the European Union (EU) which has presented challenges for manufacturers in achieving market authorizations for medicinal products. There is also uncertainty in MHRA’s participation in EU clinical trials. Thus, the MHRA has established requirements for registration of clinical trials and importing ‘Investigational Medicinal Products’.

The MHRA joined the Access Consortium, that already included national regulatory authorities of Switzerland, Singapore, Canada, and Australia, in October 2020 to enhance global cooperation among Access members and maximize efforts by agencies. This would ensure an increase in timely access to safe, effective, and high-quality medicinal products to patients. International harmonization of regulatory agencies and committees is important to ensure the most updated and consistent approach for stringent medicinal product regulation.

As a leading global contender, DDReg’s Regulatory Services in UK provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.

Our Regulatory Consulting Services In UK Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regulatory Due Diligence
  • Gap Analysis and Remediation
  • New Product Authorizations
  • Post Approval Life Cycle Management
  • CMC Advisory
  • ICSR Processing and Submission
  • Risk Management
  • Aggregate Reports
  • Signal Management
  • QPPV Services
  • Bio Waiver Justifications
  • Clinical & Non-Clinical Experts Reports
  • IPR Support, including Worldwide Patent Status and Patent Reviews
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