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Clinical Research Solutions

Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement

Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...

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Clinical Research Solutions

5 Benefits of Receiving EU PRIME Designation for Medicine Developers

What it is, why it matters, how you can apply and how we can help. What is the PRIME Scheme? You might be forgiven if you don’t know what the PRIority MEdicines (PRIME) scheme is; but if you are in...

Clinical Research Solutions

Maximising on Scientific Advice Procedures in Europe

A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...

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Clinical Research Solutions

EMA adopts first list of critical medicines for COVID-19

News On 7 June 2022, EMA's Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...

Clinical Research Solutions

CMC Regulatory Dossier Compliance: A GMP Requirement

Maintaining compliance in the dynamic regulatory Chemistry, Manufacturing and Controls (CMC field can be quite a challenge. A CMC regulatory dossier compliance assessment is a critical component and...

Regulatory Sciences

Regulatory Strategy for Clinical Trials in the European Union

Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27 individual member states each requiring its own review and approval, it...

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Regulatory Sciences

European Expedited Regulatory Programs Explained

Do you really know how to accelerate the approval of your innovative product in Europe? The FDA's incentives for promising new medicines are widely known. Accelerated approval, priority review, fast...