Integrated scientific and regulatory consulting services
Sectors
Helping you bring your medicinal products, biologics, medical devices, advanced therapies (ATMPs) and cosmetic products to market efficiently and safely.
Our clients
Since 2001, mwb consulting has been a valued and trusted partner to clients in the pharmaceutical, biopharmaceutical, MedTech, and cosmetic industries.
Our specialist medicinal products and medical device consultants continuously evaluate the regulatory landscape, leveraging our knowledge and experience to advocate for our medical device, pharmaceutical, biologics and combination product clients.
We understand the complexities of drug/device development. We can draw on expertise in non-clinical, clinical, strategic development, product safety and regulatory approval across all therapeutic areas and product/device types.
Are you a pharmaceutical company aiming to launch your first medicinal product in the EU, UK, or US market, and are you looking to take advantage of early access and accelerated pathways?
Does your biopharmaceutical enterprise need help developing a lifecycle strategy for a new biologic or advanced therapy or guidance navigating the approval process and compliance requirements in the EU, UK, or US?
Are you a MedTech business looking for support in building a medical device vigilance programme grounded in quality, compliance and efficiency?
We’re here to help.
Medicinal Products
Our specialist 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, PMDA) from non-clinical to regulatory approval.
Biologics and Biosimilars
Compared with the well-established development and approval processes for new chemical entities (NCEs) and small-molecule generics, the framework for new biological entities (NBEs) and biosimilars is highly complex and ever-evolving.
We can guide you in establishing robust and consistent strategies to ensure product quality and safety, and our regulatory experts can help you compile and submit approval documentation to ensure regulatory compliance.
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 can guide you in establishing robust and consistent strategies to ensure product quality and safety, and our regulatory experts can help you compile and submit approval documentation to ensure regulatory compliance.
Medical Devices
We have expertise in medical device development planning and advising on strategic 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).
