MWB Consulting
MWB Consulting is a global leader in pharmaceutical, biotech, MedTech, and cosmetic industry consulting, providing strategic, regulatory, and scientific support for medicinal products, biologics, medical devices, and advanced therapies. With over 20 years of proven success, they assist clients in navigating complex regulatory landscapes, optimizing product development, and ensuring compliance across the EU, UK, US, and other regions. Their services include scientific advice, regulatory affairs, product safety, legal representation, and GDPR compliance, tailored to support innovation and market entry.
Industries
Nr. of Employees
small (1-50)
MWB Consulting
Newbury, West Berkshire, United Kingdom, Europe
Products
General consulting and Troubleshooting
Expert advice and efficient solutions for medicinal product development and compliance challenges.
Advanced Therapy Medicinal Products (ATMPs) Regulatory Consulting
Integrated scientific and regulatory services to ensure the quality, safety, and compliance of advanced-therapy medicinal products such as cell therapy, gene therapy, and tissue engineering products.
EU and UK GDPR Compliance Services
Pharmaceutical products and medical device data protection services, tools, assistance, and expertise to safeguard data subjects’ privacy and ensure EU GDPR and UK GDPR compliance.
EU and UK Legal Representation
Compliant legal representation service for EU and UK regulatory purposes based on extensive knowledge of regulations and practice.
Biologics and Biosimilars Compliance Services
Integrated development and regulatory services ensuring the quality, safety, and compliance of biologic or biosimilar products throughout their lifecycle.
Pharmacovigilance and Medical Device Vigilance
Systems and expertise that help build a regulatory-compliant pharmacovigilance or medical device vigilance function, including a turn-key outsourced solution.
General consulting and Troubleshooting
Expert advice and efficient solutions for medicinal product development and compliance challenges.
Advanced Therapy Medicinal Products (ATMPs) Regulatory Consulting
Integrated scientific and regulatory services to ensure the quality, safety, and compliance of advanced-therapy medicinal products such as cell therapy, gene therapy, and tissue engineering products.
EU and UK GDPR Compliance Services
Pharmaceutical products and medical device data protection services, tools, assistance, and expertise to safeguard data subjects’ privacy and ensure EU GDPR and UK GDPR compliance.
EU and UK Legal Representation
Compliant legal representation service for EU and UK regulatory purposes based on extensive knowledge of regulations and practice.
Biologics and Biosimilars Compliance Services
Integrated development and regulatory services ensuring the quality, safety, and compliance of biologic or biosimilar products throughout their lifecycle.
Pharmacovigilance and Medical Device Vigilance
Systems and expertise that help build a regulatory-compliant pharmacovigilance or medical device vigilance function, including a turn-key outsourced solution.
Services
Ad hoc or ongoing scientific and regulatory problem‑solving across non‑clinical, clinical, strategic development and product safety issues; independent investigations and expert opinions.
End-to-end strategic planning, target product profiling, lifecycle strategy, program and protocol development, and tactical oversight of preclinical, clinical and CMC activities.
Regulatory strategy, dossier preparation and submission support for EU, UK and US authorities, including interactions with agencies and preparation for scientific advice meetings.
Managed vigilance service covering case intake, triage, assessment, MedDRA coding, reporting, aggregate reporting and provision of QPPV and responsible persons.
Compliant legal representation and regulatory office services for sponsors needing an EU or UK legal contact for clinical trials, marketing authorisations, orphan designation and liaison with authorities.
Sector-specific data protection and privacy advisory for clinical data processing to achieve EU and UK GDPR compliance, delivered via specialist privacy collaboration.
Ad hoc or ongoing scientific and regulatory problem‑solving across non‑clinical, clinical, strategic development and product safety issues; independent investigations and expert opinions.
End-to-end strategic planning, target product profiling, lifecycle strategy, program and protocol development, and tactical oversight of preclinical, clinical and CMC activities.
Regulatory strategy, dossier preparation and submission support for EU, UK and US authorities, including interactions with agencies and preparation for scientific advice meetings.
Managed vigilance service covering case intake, triage, assessment, MedDRA coding, reporting, aggregate reporting and provision of QPPV and responsible persons.
Compliant legal representation and regulatory office services for sponsors needing an EU or UK legal contact for clinical trials, marketing authorisations, orphan designation and liaison with authorities.
Sector-specific data protection and privacy advisory for clinical data processing to achieve EU and UK GDPR compliance, delivered via specialist privacy collaboration.
Expertise Areas
- Regulatory compliance and market authorisation (EU/UK/US)
- Clinical trial design and trial management
- Pharmacovigilance and medical device vigilance
- Strategic product lifecycle planning and target product profiling
Key Technologies
- Regulatory submission portals (CTIS and national portals)
- Adverse event reporting databases (EudraVigilance-style systems)
- Pharmacovigilance case management systems
- MedDRA coding and terminology
News & Updates
Guidance on preparing and submitting Paediatric Investigation Plans (PIPs) in the EU, including timelines, requirements, and working with regulators.
Insights into the orphan drug designation process in the EU, eligibility criteria, application steps, and post-designation obligations.
Navigating new European Union Clinical Trials Regulation (CTR) processes: a guide to ongoing changes
Overview of the new EU Clinical Trials Regulation, its impact on trial processes, and how to adapt to the new requirements.
Step-by-step guidance on obtaining scientific advice from the EMA, including preparation, meetings, and implementation.
A detailed case study on how MWB Consulting assists US-based pharmaceutical companies in navigating the European regulatory landscape.
An overview of how strategic consulting can streamline development and regulatory approval processes.
Guidance on preparing and submitting Paediatric Investigation Plans (PIPs) in the EU, including timelines, requirements, and working with regulators.
Insights into the orphan drug designation process in the EU, eligibility criteria, application steps, and post-designation obligations.
Navigating new European Union Clinical Trials Regulation (CTR) processes: a guide to ongoing changes
Overview of the new EU Clinical Trials Regulation, its impact on trial processes, and how to adapt to the new requirements.
Step-by-step guidance on obtaining scientific advice from the EMA, including preparation, meetings, and implementation.
A detailed case study on how MWB Consulting assists US-based pharmaceutical companies in navigating the European regulatory landscape.
An overview of how strategic consulting can streamline development and regulatory approval processes.