Large Compliance Project Consulting
Q&C® can help your company deal successfully with any size of project, from a large multi-faceted quality initiative to the most specialized task, from the design of a complete quality system through to assistance with its implementation.

Working closely with your staff, we are able to look at your processes objectively to determine your needs and priorities. We tailor our services accordingly using our proven processes and templates to provide a practical, efficient and cost-effective approach to your project. 		vertical dots You will receive excellent customer service and benefit from our strong project management skills as we move the project forward in a timely, cost-effective manner.

We are committed to conceiving, developing, and implementing strategies and processes to improve quality and efficiency aligned with your priorities. Our associates' excellent project management skills are complemented by their ability to work with the client in utilizing their systems and their personnel to complete the project.
We Offer:
  • Management of large compliance projects
  • GMP for clinical trial materials
  • Health Canada audit corrective action projects
  • Backlog cleanups - stability reports, change controls, deviations, batch record reviews, etc.
  • Interim QCO Services for fabricators - managing your quality system during periods of growth and/or transition
For large compliance projects, if desired, we can identify your priorities and address them in a straightforward, systematic manner using
 The Quality Plan™.

The Quality Plan™ focuses on your specific quality needs, and ensures:

  • You meet all regulatory requirements so you are proactive and more knowledgeable than any visiting auditing team
  • Improved efficiency in the use of your quality resources
  • Your quality systems are always under control, with the status of ongoing activities readily available at all times
  • Continual quality improvement within well-defined budgets
 vertical dots It provides peace of mind and allows for careful resource allocation and is vital in setting long and short term priorities. We develop The Quality Plan™ from information gathered in The GMP Gap Analysis™. This plan includes actions (quality initiatives) with targeted completion dates for the core GMP quality components. It helps:
  • Provide a detailed long-term roadmap to compliance
  • Prioritize quality activities
  • Assist with addressing outstanding issues from previous audits
  • Work as a communication tool for all parties involved
    If you prefer, Quality & Compliance Services Inc. can help expedite the implementation of your Quality Plan™ by corresponding with - and providing ongoing guidance to - a key contact in your company who coordinates the onsite work. We have mentored a number of clients in this manner with great success.

As we are a full-service company, we can provide expertise and assistance with all aspects of quality and compliance, including auditing, validation, Quality Control Officer, technical writing, GMP training, regulatory, and lab services.
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Go to our Audits page for more information about The GMP Gap Analysis™ and our auditing services.


  Our Services
Quality & Compliance Services Inc. (Q&C®) provides
expert assistance at every stage of a GMP compliance program. We have a team of full-time, dedicated, diversified, committed and knowledgeable specialists; our associates are assigned to a given project to meet a client's particular needs. Q&C® is able to flex to meet changing project scopes (e.g., tightened timelines, market changes, short-term workforce shortages, etc.).

Why Hire Us for Large
Compliance Project Consulting?
  1. Employing Q&C® as your QA personnel will allow you to focus on your day-to-day activities with the assurance your quality system is being maintained in a compliant manner.

  2. As we are a full-service company, we can provide expertise and assistance with all aspects of quality and compliance, including auditing, validation, Quality Control Officer, technical writing, GMP training, regulatory, and lab services.

  3. We tailor our services using our proven processes and templates to provide a practical, efficient and cost-effective approach to your project.

  4. We employ a team approach to fully address your needs. We have many highly qualified full-time consultants/associates; your staff will benefit from their broad-based knowledge and experience in quality control and quality assurance, GMP/NHP/cGMP, and technical documentation.
Other Services
pdf icon Summary of Our Services