In Apr-13, the Medicines and Healthcare products Regulatory Agency (MHRA) successfully prosecuted an individual for manipulating pre-clinical analytical data. Following identification of irregularities in the bioanalytical data, the MHRA was notified and the following...
The Guideline for Good Clinical Practice (GCP) E6(R1) has been undergoing revision since Jun-15 and the revised guidance, the Integrated addendum E6(R2) (‘the addendum’) is planned for finalization soon. While the addendum includes few additions to investigator...
Enhancing Good Pharmacovigilance Practice with ADAMAS Consulting
DIA 2024 Global Annual Meeting | San Diego, CA
Come and meet ADAMAS Consulting at the RQA European QA Conference, Belfast
Computer Software Assurance (CSA): Why the Change and What Does it Mean?
Annex 1 Revisions: What are the Changes and Whom will they Affect?