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.
Why Choose DDReg for Regulatory Services in UK
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 in UK portfolio covers:
01
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
02
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
03
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
04
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
05
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
06
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
07
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
08
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
09
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
10
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
