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EMA Publishes Updated Guidance on Nitrosamines Impurities
Latest news from EMA regarding nitrosamines
Marketing Authorisation Holder GMP-related Responsibilities
Our latest regulatory update focuses on the responsibilities of the Marketing Authorisation Holder.
Clinical Development Practices & Regulations
Our latest Industry Update for Q2 covers the latest regulatory information around COVID-19 and much more.
Nitrosamine Risk Evaluation for Marketing Authorisation Holders
The deadline for Nitrosamine Risk Evaluation is looming. Are you ready?
MAH Nitrosamine Risk Evaluation update – 1 month to go
With just one month to go, have you completed your risk evaluations? Make sure you are ready!
Nitrosamine MAH Risk Assessment – Two Months to Go
Two Months to Go – Human medicinal product licences to be reviewed for the presence of Nitrosamine Impurities
Nitrosamines, TOPRA, Drug Development News
Nitrosamines, TOPRA, & Drug Development News are the focus for our Q4 Industry Insights
SME Day at EMA – Part 3
The final report on the SME Day at EMA focuses on the Committee for Advanced Therapies, new Medical Devices Regulation and a Brexit update.
SME Day at the EMA – Part Two
Part Two of the report from the SME Day at the EMA focuses on Marketing Authorisations and more.
SME Day at the EMA – Part One
Larissa Gould reports from the EMA in Canary Wharf on the latest developments.