Compliance Solutions to help you to achieve compliance to TGA, FDA, Medsafe, MHRA and Health Canada regulations.

Compliance is at the forefront of pharmaceutical companies' minds today. It can be defined as the set of activities that companies must undertake to meet all regulatory requirements. Without an adequate compliance program, companies can face the threat of fines and more scrutiny from regulatory bodies. Compliance activities can be complex and time consuming, and guidance’s can be inherently risky to interpret without a degree of assistance from experienced practitioners.
Tightening of the governance of areas such as electronic records and signatures, equipment installation and operation, and the validity of test results means that there are frequent changes to the steps required to ensure that audit and filing deficiencies are kept to a minimum.

Our consultants have broad exposure with requirements to meet the expectations of regulatory bodies both in Australia and overseas markets.

Our compliance services include (but are not limited to):


 

Our consultants have in-depth experience in the implementation and maintenance of documentation systems. They are able to generate documents from the product development stages through to full commercial (QA) systems. Some examples of the documentation that can be designed and/or provided by our consultants are:

  • Standard Operating Procedures
  • Analytical testing procedures
  • Method Validation protocols and reports
  • Manufacturing Validation protocols and reports
  • Cleaning Validation protocols and reports
  • Stability Protocols.

 

Our consultants have extensive and up-to-date experience with regulations covering a broad range of systems and activities. They are able to advise on the best way forward, or alternatively, can manage the activities for you. Our compliance services include:

  • Consultation for developing a compliance documentation framework
  • Analytical equipment selection (including generation of URS), purchase and commissioning
  • Analytical equipment validation and calibration design, protocols, reports and execution
  • PIC/S, GAMP and 21 CFR Part 11 compliance evaluation, strategy planning and execution
  • Laboratory Occupational Health and Safety systems
  • Design and plan analytical development strategy

 

Any new software application requires appropriate validation to ensure it is in compliance with all relevant standards. Our consultants have hands-on experience in designing appropriate validation protocols, testing regimes and final reports for small and large applications. From your HPLC software system to large electronic document management systems, we can help you fulfil your regulatory requirements. Our services in this area include:

  • Writing validation protocols
  • Designing User Acceptance Testing protocols
  • Writing validation reports

 

If you would like to discuss your needs with us and see how we can help you, contact us!