A pharmaceutical regulatory training business offering affordable, high-quality public conferences/seminars and in-house training on pharmaceutical issues to help companies create successful applications for Clinical Trials (CT) and Marketing Authorisation (MA) approvals

Courses are delivered by experienced lecturers most of whom have worked as Licensing Authority Experts or Regulatory Assessors.  Current and forward-looking training is provided in EU regulatory subjects especially those involving chemistry and pharmacy (pharmaceutical) topics, sometimes with added focus on nonclinical and clinical subjects, all of which can feature in the Modules of the Common Technical Document (CTD)

also provides at a company’s request tailor-made courses with pharmaceutical regulatory insight connected with chemistry, manufacturing and control (CMC)

Good regulatory practice and individual professional codes require staff to be trained appropriately and to keep up-to-date their professional competences for their work in pharmaceutical regulatory affairs

Where the development and licensing of medicines are concerned, major work areas for regulatory staff are

• clinical trials on investigational medicinal products (IMPs)
• preparation of dossiers and documents for Marketing Authorisation Applications (MAAs)
• the maintenance of approved Marketing Authorisations (MAs)