Regulatory

For all Regulatory Affairs, Onorach™ is pleased to be able to partner with The Whipps Consultancy.

Cheynee Whipps has over 25 years experience in regulatory compliance covering European and US requirements for medical devices and pharmaceuticals.

She is a registered Qualified Person (QP) for release of medicinal products in accordance with Article 49 of EEC Directive 2001/83/EC (permanent provisions). For 15 years Cheynee was also a QP assessor appointed by the Society of Biology on behalf of the UK Medicines and Healthcare products Regulatory Agency, latterly as chair of Society of Biology assessors.

Cheynee has led product development programmes from concept to market, successfully registered products and implemented relevant quality management systems necessary to market these products. This means direct interaction with worldwide regulatory agencies involving negotiation, written and verbal communication, and interpersonal skills.

Client Testimonial

We're impressed with the services Onorach offer and the expertise that underpins this and look forward to further discussions on partnerships for clinical development in the near future
Novabiotics - Aberdeen

 

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