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EU Paediatric Investigation Plan preparation and submission: your strategy for success
What is a paediatric investigation plan? An EU Paediatric Investigation Plan (PIP) is a development plan that supports the authorisation of safe, effective and high-quality medicines for children in the … Read more
EU Orphan Drug Designation (ODD): overcoming key challenges during preparation, submission and beyond
Orphan drugs are medicines involved in the diagnosis, prevention and treatment of rare diseases which affect a relatively small number of people within the broader population. In the EU, over … Read more
Navigating new European Union Clinical Trials Regulation (CTR) processes: a guide to ongoing changes
The new Clinical Trial Regulation (CTR) has brought the most significant change to the regulatory landscape in decades, and its introduction affects virtually every aspect of clinical trial operations. The … Read more
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
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 … Read more
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 … Read more
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 … Read more