Medicinal and Biologics

Our experience in Medicinal Drug Consultations

Medical Device

2019 was a year of firsts for BSI, and 2020 kicks off with another fantastic achievement as we become the first ever to issue a Notified Body Opinion to a manufacturer for a drug-device combination product under MDR Article 117. This is thanks to the team for working incredibly hard to provide this expertise to our clients. Read more on this article.

 

BSI is delighted to announce the formation of a new technical Conformity Assessment team focusing on Medicinal Products and Biologics. Dr Jennifer Durrant has taken up the position of Global Head, Medicinal and Biologics Team. Dr Durrant worked on the BSI General Devices Team for over nine years prior to this, and has a wealth of experience and success in many of the areas within the scope of the new team.

Medical Products

Over 55 years of combined experience

The four team members are experienced in drug development, QBD, GMP systems and controls in addition to interactions with Competent Authorities, and will be valuable in supporting Medical Devices containing or used with medicinal substances. 

Dr. Susanne Fornero-Quaak

  • Trained as a Pharmacist at Utrecht University.
  • PhD in Pharmaceutical Sciences from Utrecht University.

Dr. Jon Sutch

  • Trained as a Pharmacist at the London School of Pharmacy.
  • PhD in Pharmaceutical Sciences at Nottingham University. 

Dr. Arabe Ahmed

  • Trained as a Pharmacist at the University of Aston in Birmingham, graduating with a BPharmS.
  • Master’s degree in Pharmaceutical Technology at King’s College London.
  • PhD in Pharmaceutical Sciences from Julius Maximilian University, Würzburg (JMU), Germany.

Dr. Godwill Iheagwaram

  • Trained as a pharmacist at The University of Strathclyde.
  • PhD from The School of Pharmacy at Queens University, Belfast.

Drug-device combination products under MDR Article 117

Amendment to Directive 2001/83/EC – medicinal products for human use. Manufacturers of combination products regulated as medicinal products need to be aware of the changes brought about by the MDR. For drug device combinations marketed as medicinal products where the combination is placed onto the market as an integral product, Notified Body involvement is required to confirm compliance with applicable General Safety and Performance Requirements. BSI will provide an opinion to the Medicines Competent Authority reviewing the product to confirm compliance.

Manufacturers of combination products will need to obtain the services of a Notified Body; come and talk to BSI early in your planning.

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