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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
  • API/DMF

    Our Regulatory Affairs Consulting Services portfolio covers:

    Strategies

    Regulatory Strategies / Expert Views

    Regulations pertaining to pharmaceutical products are continuously changing...

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    Authorizations

    New Product Authorizations

    Pharmaceuticals and other medicinal products need to be prior authorized by...

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    Analysis

    Gap Analysis and Remediation

    A gap analysis is a regulatory review process that identifies data gaps in the technical...

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    delig

    Regulatory Due Diligence

    Regulatory issues arise unexpectedly and can create significant strain on a company’s...

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    Authorizations

    API/DMF

    DDReg provides expert consulting and efficient services for quality Drug Substance...

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    CMC

    CMC Advisory

    When it comes to regulatory strategies, CMC documentation play a crucial role in developing...

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    Post Approval Life Cycle Management

    Managing the post-approval life cycle of a product is an essential component to sustaining...

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    Regulatory Certification

    Regulatory Certification

    Administrative documents are an integral component of regulatory submissions and constitute key certifications...

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    Regulatory Certification

    ANDA and MA Holder Services

    The regulatory approval pathway for Abbreviated New Drug Applications (ANDAs) is relatively complex....

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    Call us on:+1 (302) 601-2755