Scottish Health Innovations Ltd

Consultancy Services

SHIL's Consultancy Services for industry seeking regulatory approval and developing quality management systems.


Providing practical and cost effective solutions to help you get your products to market on time and on budget.

SHIL offers consultancy specialising in regulatory compliance for product development and manufacture, combining Regulatory and Quality Management expertise.  

This area of SHIL is headed up by Head of Regulatory Consultancy, Cheynee Whipps. 

Services include:
  • Implementation of and monitoring quality assurance systems to ensure compliance with BS EN ISO 13485 for medical devices and EU Commission Directive 2003/94/EC covering GMP for medicinal products for human use and investigational medicinal products for human use.  Experience covers UK MHRA and US FDA
  • Auditing to GXP standards, covering manufacture, testing, distribution and clinical research
  • Clinical development plans, management of clinical trial supplies and clinical monitoring
  • Preparation and monitoring of project plans to develop medical devices and pharmaceutical products from inception through to regulatory submission and launch
  • Regulatory strategies for product licensing and approval, US and Europe
  • Liaison with regulatory agencies
  • Transfer and validation of processes from development to production
For further information please contact:

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www.shil.co.uk
+44(0)141 248 7334
 

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