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Track record of meeting and overcoming regulatory challenges and using the regulatory environment to advantage

Regulatory Affairs

Working with you to present your product and development strategy to regulatory agencies, ensuring legal requirements are met along the way.
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Our experienced regulatory affairs professionals draw on their in-depth knowledge of the medicinal product and medical devices regulatory landscape across the EU, UK, and US.

Interpreting regulatory agency requirements and trends, formulate submission strategies, prepare and review documentation such as dossiers, and manage applications to appropriate regulatory authorities.
We also bridge the gap between pharma and biotechnology businesses and regulatory agencies, communicating directly with the European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Food and Drug Administration (FDA), responding promptly to queries and ensuring all registrations and approvals are granted without unnecessary delays.
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Examples include:
• Interpreting EU, UK and US agency requirements/trends and design subsequent regulatory strategy
• Hold SME designation - Providing EU/UK representative office for EMA/EU National Competent Authorities (NCAs)/MHRA liaison
• Managing regulatory agency submissions and interactions and attending meetings (worldwide), giving expert advice on the outcomes of meetings
• Hold Orphan Drug Designation
• Successful defence and approval of challenging submissions for Paediatric Investigation Plans (PIP)
• Generation of multiple clinical trial applications, including managing the Clinical Trial Information System (CTIS) process and UK IRAS system
• Attend EMA meetings, including Innovation Task Force (ITF) meetings, Pre-Marketing Authorisation Application (MAA) meetings
• EMA and NCA liaison (e.g. EMA Scientific Advice, National Scientific Advice, Paediatric Scientific Advice)
• Subject Matter Experts for FDA meetings
• Advising on and managing application and maintenance of accelerated programmes with EMA, MHRA and FDA, including PRIME

Need support for your clinical development project?

Do you need to troubleshoot regulatory or clinical trial issues?

Contact us today for an initial, free-of-charge discussion with a senior consultant about your project-related problems or issues.