Wainwright Associates
Submission of labels and leaflets in the UK
April 5, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Labelling, Wainwright Associates
The MHRA has announced procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets for medicinal …
On-going Medicine evaluation Information to be published by European Medicines Agency
February 24, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates
Following the recommendations on transparency published by the European Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), …
MHRA Inspections of CROs
January 24, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Audits, Wainwright Associates, inspectons
In accordance with the provisions of the new pharmacovigilance legislation, as per Directive 2010/84/EU, EU Competent Authorities may inspect the …
Payment changes of authority’s fees in France
January 20, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates, regulatory affairs
Changes are being made in the way fees are paid for regulatory submissions and procedures in France. Fees are no …
Changes to the EMA’s registration process for SMEs
November 22, 2011Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates
The European Medicines Agency (EMA) has recently made changes to its process for the registration of micro, small or medium-sized …
Pharmacovigilance Compliance Report submission; MHRA’s Risk Based Compliance Programme
September 20, 2011Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing PV, Wainwright Associates
A new version of the MHRA pharmacovigilance Compliance Report (Good Pharmacovigilance Practice Questionnaire) has been released by the MHRA.Submission of …
First Paediatric Use Marketing Authorisation Granted
September 14, 2011Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates
The European Commission has granted the first ever children’s medicine to hold a new Paediatric Use Marketing Authorisation (PUMA). The …
Joint API inspection pilot proves successful
August 17, 2011Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates
Over recent years compliance with GMP in the manufacture of active substances (APIs) has been the subject of increasing regulatory …
Meet Wainwright Associates at the TOPRA Symposium and CPhl worldwide
August 7, 2011Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates
Wainwright Associates is an independent company offering consultancy services to the pharmaceutical, medical device and healthcare industry in Product Development, …
EU Clinical Trials Register is Launched
March 29, 2011Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates
The European Medicines Agency (EMA) has announced the launch of its EU Clinical Trials Register. This online register allows public …
