Consulting and contracting to the Pharmaceutical, Medical Device and Biotech Industries

We perform the following services on either an hourly-rate basis, or at a fixed price. 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.

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, TGA),
Part 11 and Annex 11 compliance to FDA and TGA requirements
Pharmaceutical Maintenance we can audit for compliance to TGA, 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.
We assist with Veterinary Drug GMP compliance to the APVMA GMP code.
Quality Assurance Outsourcing is not limited to smaller companies. Multi-national's with established QA departments often need to overcome staffing shortages, have their staff trained or obtain independent advice.

Validation - Process, Equipment & Computer

Pharmaceutical and Medical Device Process Validation to TGA 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

Continuous Improvement - Lean Manufacturing, Six Sigma, 5S

Continuous Improvement, Lean Manufacturing, World Class Manufacturing projects are difficult to initiate and implement as the highly regulated Pharma environment. Why not talk to our experts, knowledgeable in Lean Manufacturing, Six Sigma, 5 S etc and GMP requirements.