Pharmaceutical, Medical Device and Biotech manufacturing consultants

Our services are available on an hourly-rate basis, or at a fixed price. Our staff can work either in our office or on your site. You can hand over the whole project for us to manage or you can use our staff for specific tasks within a project. Choose the arrangement that suits you best.

Our range of services includes:

People

Outsourced consultants to work on your site under your direction at short notice for short or long duration projects. We have Pharmaceutical Engineers, GMP Consultants, Validation Consultants and Technical Document Writers available at short notice at competitive rates.
We supply Engineers to review your plant design as well as other general engineering services.

GLP / GMP Compliance

GCP/GLP/GMP Quality Management Systems or Quality Management Systems or GAP audits and assessments
Practical recommendations and advice on the implementation of ISO 9001 for Pharmaceutical or ISO 13485 for Medical Device Quality Management Systems, Policies, SOP and Forms.
International Regulatory GMP assistance to obtain approval from the following international regulatory authorities (FDA, MHRA, Medsafe),
Part 11 and Annex 11 compliance to FDA requirements
Pharmaceutical Maintenance we can audit for compliance to MCC, FDA and ISPE baseline recommendations.
Managing pharmaceutical and food manufacturing facility projects to ensure regulatory compliance.
Specific training targeted at an identified need within your company, however we do provide specific training for ISO 13485.

Validation - Process, Equipment & Computer

Pharmaceutical and Medical Device Process Validation to MCC and FDA regulations,
Pharmaceutical Equipment Validation to international regulatory standards and in accordance with current Good Manufacturing Practice.
Cleaning Validation for pharmaceutical and medical device manufacturing facilities