Regulatory Affairs
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. The process of marketing medicines and medical devices in the EEA involves navigating intricate procedures and stringent requirements and gaining a thorough understanding of the … Read more
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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. To help drug sponsors navigate this journey, the European Medicines Agency (EMA) offers valuable support through scientific advice and protocol assistance programs. This article outlines … Read more
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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 this increasingly complex regulatory landscape is crucial for successfully bringing products to market. This article summarises the different types of approvals for drugs and medical … Read more
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Sponsor’s legal representation in EU and UK: How a pharmaceutical consultancy can help you meet your regulatory requirements
Organisations based outside the EU and UK must have the correct legal representation in place before they: Appointing legal representation is a crucial step in meeting regulatory requirements and helps reduce the cost and time required to navigate a demanding regulatory landscape. That’s why many organisations choose to work with pharmaceutical consultancies, like MWB Consulting, … Read more
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The importance of investing in strategic regulatory affairs consulting
The development process for medicinal products and medical devices is complex and highly regulated, and the pharmaceutical industry is evolving faster than ever. So, staying compliant with regulations is becoming ever more challenging. To do this successfully, it’s vital that businesses of all sizes invest in strategic regulatory affairs to develop a comprehensive approach to … Read more
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The Benefits of Pharmaceutical Consulting in Medicinal Product, Biologic, Advanced Therapeutic and Medical Device Development
The drug or medical device development process is complex and can be challenging for any organisation. However, this journey becomes more manageable with pharmaceutical development and regulatory consultants’ strategic guidance and regulatory expertise. These experts can guide you from the preclinical stage through clinical trials, approval, and product launch. Launching a drug (small molecule or … Read more
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