Pharmaceutical Medical Device and Biotechnology Consultants

Our Quality and Validation services are available on an hourly rate basis, or at a fixed price. Our professional trainers can go to your site and train your employees. Or you can use our other professional staff for specific tasks within a project.

Choose the arrangement that suits you best.

The services we offer are:

Training on GMP/GLP Compliance

Training on PIC/s and other GMP Quality Management Systems regulations.
Practical recommendations and advice on implementation of ISO 9001 for Pharmaceutical or ISO 13485 for Medical Device Quality Management Systems, Policies, SOP and Forms.
International Regulatory Auditing assistance to obtain approval from the following international regulatory authorities (FDA, HSA, WHO)
Expert coaching on 21 CRF Part 11 and Annex 11 compliance to FDA requirements
Managing pharmaceutical and food manufacturing facility projects to ensure regulatory compliance.
Customised training targeted at than identified need within your company, however we do provide specific training for ISO 13485.
Process Validation Training in Pharmaceutical and Medical Device companies to comply with HSA, WHO and FDA regulations.
Equipment Validation Training to international regulatory standards and in accordance with current Good Manufacturing Practice.
Cleaning Validation Training for pharmaceutical and medical device manufacturing facilities.
Computer System Validation Training to comply with GAMP and 21 CFR Part 11 or Annex 11 requirements.

People

Professional trainer to go to your site to teach your employees about GMP compliance.
We have Pharmaceutical Engineers, GMP Consultants, Validation Consultants and Technical Document Writers available at short notice tat competitive rates.

Drug Registration

We can help you prepare the dossiers necessary to submit drugs for registration with international regulatory bodies, specialisation, Australia and New Zealand.