Standards & Regulation

Pharma companies have been raising awareness for years, but patients continue to buy counterfeit medicines online.

From patient-centric design to speciality excipients and security of supply; what are the latest trends in formulation strategies?

Industry experts share how their therapeutic products are shaping the future of the pharmaceutical landscape.

Is the regulator environment changing fast enough to accommodate the vast array of microbiome-based therapeutics beginning to emerge?

Combine standardized, single-use platform technologies that can be customized to your particular process requirements, for crucial efficiency gains.

What are the most important things to consider when filing an IND? This infographic, sponsored by Regis, sets out the five key steps to success.

GDUFA fees for 2020 have been decided – and include a significant drop in the fees for finished dosage facilities.

With a no-deal Brexit still a real possibility, Merck continues to prepare for the worst case scenario.

Our animation explores the unique challenges a "no-deal" Brexit poses for the drug development and advanced therapy sectors.

Qualitative risk assessments are a great way to approach quality management and train your operators at the same time.