A valued partner to our global clients since 2001
The Pharmaceutical Consultancy
Integrated consulting services to help you bring your products through their development efficiently.
Are you a pharmaceutical, biotech or medtech company needing help with strategic planning or navigating the complex EU and UK regulatory landscapes?
— Our consultants are here to advise and help you.
In-depth scientific knowledge and expertise
Seamless communication, data security and compliance
Trusted, collaborative partnership
Extensive regulatory understanding and know-how
Your outsourced product vigilance service
Effective and rapid problem-solving
Proven success
mwb consulting
Using our in-house team and associate consultants in the MWB Consulting network™, we consult on individual scientific and regulatory projects, troubleshoot specific issues, or form specialised teams that help you achieve your objectives.
Integrated consulting services for the development of new medicines and medical devices
Services
General Consulting and Troubleshooting
Efficient, compliant advice when you need it the most. We consult on an ad hoc basis or can help solve specific project issues on a continuous basis.
Strategic and Tactical Medicinal Product and Medical Device Development
End-to-end strategic planning and tactics to improve time to market, control costs, plan timelines, and maximise the probability of successful regulatory approval.
Regulatory Affairs
EU, UK and US regulatory guidance, knowledge and support. Working with you to navigate requirements to present your product and strategy to regulatory agencies.
Pharmacovigilance and Medical Device Vigilance
Systems and expertise that help you build a regulatory-compliant pharmacovigilance or medical device vigilance function, including a turn-key outsourced solution.
EU and UK Legal Representation
Compliant legal representation service for EU and UK regulatory purposes based on an extensive knowledge of regulations and practice.
EU and UK GDPR Compliance Services
Our sister consultancy, Pharma Data Protection SARL, offers a combination of pharma and data privacy expertise dedicated to the pharmaceutical industry.
General Consulting and Troubleshooting
Efficient, compliant advice when you need it the most. We consult on an ad hoc basis or can help solve specific project issues on a continuous basis.
Strategic and Tactical Medicinal Product and Medical Device Development
End-to-end strategic planning and tactics to improve time to market, control costs, plan timelines, and maximise the probability of successful regulatory approval.
Regulatory Affairs
EU, UK and US regulatory guidance, knowledge and support. Working with you to navigate requirements to present your product and strategy to regulatory agencies.
Pharmacovigilance and Medical Device Vigilance
Systems and expertise that help you build a regulatory-compliant pharmacovigilance or medical device vigilance function, including a turn-key outsourced solution.
EU and UK Legal Representation
Compliant legal representation service for EU and UK regulatory purposes based on an extensive knowledge of regulations and practice.
EU and UK GDPR
Our sister consultancy, Pharma Data Protection SARL, offers a combination of pharma and data privacy expertise dedicated to the pharmaceutical industry.
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.
we cover many, here are a few
Sectors
Medicinal Products
Our team of pharmaceutical consultants offer scientific expertise, specialised knowledge, and experience across all phases of medicinal product development and the intricacies of regulatory compliance (EMA, MHRA, FDA) from non-clinical to regulatory approval.
Biologics and Biosimilars
Do you need timely, accurate, and up-to-date advice regarding the diverse and sometimes confusing license applications and regulatory approval processes? Our experts can help you avoid unnecessary launch delays and ensure you meet regulatory requirements.
Advanced Therapy Medicinal Products
Advanced therapy medicinal products (ATMPs) face several challenges during development, approval and postmarketing, including uncertainty about the product's benefit-risk balance, limitations of nonclinical development, and complex quality aspects of highly individualised advanced therapies.
We have in-depth knowledge and expertise in the regulatory approval processes for innovative therapies that mainly target orphan diseases and high unmet medical needs.
Medical Devices
We have expertise in medical device development advising on regulatory planning and compliance. We can help you navigate the increasingly complex regulatory environment regarding medical devices (including drug-device and device-drug combinations) and in-vitro diagnostics (EU, UK and US Medical Devices Regulation).
Medicinal Products
Our team of pharmaceutical consultants offer scientific expertise, specialised knowledge, and experience across all phases of medicinal product development and the intricacies of regulatory compliance (EMA, MHRA, FDA) from non-clinical to regulatory approval.
Biologics and Biosimilars
Do you need timely, accurate, and up-to-date advice regarding the diverse and sometimes confusing license applications and regulatory approval processes? Our experts can help you avoid unnecessary launch delays and ensure you meet regulatory requirements.
Advanced Therapy Medicinal Products
We have in-depth knowledge and expertise in the regulatory approval processes for innovative therapies that mainly target orphan diseases and high unmet medical needs.
Advanced therapy medicinal products (ATMPs) face several challenges during development, approval and postmarketing, including uncertainty about the product's benefit-risk balance, limitations of nonclinical development, and complex quality aspects of highly individualised advanced therapies.
Medical Products
We have expertise in medical device development advising on regulatory planning and compliance. We can help you navigate the increasingly complex regulatory environment regarding medical devices (including drug-device and device-drug combinations) and in-vitro diagnostics (EU, UK and US Medical Devices Regulation).
Mwb consulting
Key numbers and success rates
20+ years of proven success in providing effective solutions to the global pharmaceutical/biotech and medical devices industry
Multiple regulatory submissions with high success rates, notably in orphan designation and paediatric development
Input into many innovative products now on the market, including biologics, small molecules, and cell and gene therapies
Long client retention, an average of 10 years
No issues covering different time zones
Global clients
We have over two decades of proven success in providing effective solutions to the global pharmaceutical/biotech and medical device industries.
We support businesses across the globe
Knowledge hub
Latest Insights
Marketing medicines and medical devices in the EEA
The pharmaceutical and medical device development landscape is complex, so companies looking to market their products in the European Union (EU) and European Economic Area (EEA) face a daunting challenge. … Read more
Getting scientific advice from the EMA: A guide to working with the Scientific Advice Working Party
Drug development is a long, complex and expensive process. Errors, missing documentation or unclear technical information can result in costly delays and even prevent a drug from gaining market authorisation. … Read more
An introductory guide to navigating the FDA approvals process and regulatory landscape
If you’re a pharmaceutical, biotech or medtech business entering the US market, the Food and Drug Administration (FDA) approvals process for new drugs and devices can be daunting. But understanding … Read more
