Pirus Consulting Ltd
Medical Devices, Biopharmaceuticals and Pharmaceuticals Regulatory and Quality Management consultancy.
|Address:||Quern House, Mill Court,, Great Shelford, Cambridge|
|Membership type:||Professional Individual and Corporate < 5 (£50+VAT pa)|
With more than 25 years experience in the in the biopharmaceuticals and medical devices industries Pirus Consulting has provided expert advice in the areas of Quality Management Systems, technical dossier design and CMC in the Medical Device and Biopharmaceuticals regulatory filings respectively.
Pirus Consulting has a technical approach and a breadth of knowledge which includes all aspects of product realization ranging from discovery and development through to manufacture and regulatory filing. This breadth of experience also enables Pirus Consulting to develop regulatory pathways in new technologies where required.
Our tailor made approach based on quality by design together with our technical knowledge enables us to anticipate and devise strategies to avoid/overcome many regulatory obstacles to the benefit of our clients.
Pirus Consulting Ltd is an independent consultancy providing Regulatory and Quality Management advice to companies with high technology products in Medical Device and Bio/pharmaceutical sector.
Dr Mehryar Behizad, Principal Consultant of Pirus Consulting, was invited by The Organisation for Professionals in Regulatory Affairs (TOPRA) to join its Special Interest steering committee in Medical Devices in September 2016. This has given the firm an opportunity to make a contribution to the regulatory knowledge in this field.
1 December 2017Read in full
Increasing application of software in medical devices necessitates compliance to the IEC/ISO 62304 International Standard for software lifecycle management. A paper published by Dr Mehryar Behizad of Pirus Consulting in the Regulatory Rapporteur outlines the regulatory position in this area.
6 June 2016Read in full
Increasing demand for high quality data by the regulators from medical and healthcare innovators at an early stage of product lifecycle is explored in an article The Shrinking Black Box. A discussion of practical steps for innovators to ensure high quality data will be presented in Ensuring a Solid Foundation as part of One Nucleus Life Science Leadership Series at 2:00pm on September 24th.
14 September 2015Read in full
Pirus Consulting is delighted to accept the invitation to provide a Clinic session on Regulatory Issues as part of the Ignite programme at the Cambridge Judge Business School.
25 June 2015Read in full
The changing regulatory landscape and increasing complexity of technologies require a new approach to compliance thinking, says Pirus Consulting.
18 June 2015Read in full