IMPORTING | REGULATORY | GMP COMPLIANCE
The First Name Worldwide in Canadian Pharmaceutical Consulting.
For 30 years we’ve been assisting companies in:
We have learned that good advice comes from understanding that there is a difference between how the rules are written, how they are interpreted, and how they are enforced.
Anyone can read the rules: we understand them.
Our Services
Q&C Services is recognized as a standard-setting organization that prioritizes insight, creativity, and innovation for a new level of excellence in quality and compliance. Each year we host many audits and interact with regulators frequently. With over 40 consultants from varied backgrounds, Q&C Services can match your needs with the best people for the job.
Audits
If you are concerned about getting a poor inspection rating, want to reduce risk classifications of observations, or you are struggling with representing your quality systems, call us to book your internal audits.
Expert Witness Consulting
Need an expert witness or analysis for upcoming legal proceedings? Q&C Services provides expert witness consulting and support to help legal teams build the strongest case possible.
Facility Licensing
With years of experience in DEL, NHP Site License and MDEL applications, maintenance, amendments and renewals, we’re your go-to resource for licensing.
GMP Compliance Services
From large, multi-faceted quality initiatives to the most specialized tasks, we bring deep expertise, complimentary skill sets, and built in back-up to every assignment.
Importing
Navigating Canadian regulations for importing a regulated product can be complicated and costly. Our Rapid Release Team™ makes it faster and simpler to get your product to the Canadian marketplace.
Pharmacovigilance
Q&C Services offers expert guidance and support to assist you in developing and implementing effective pharmacovigilance strategies that meet regulatory requirements.
Regulatory Services
Q&C Services helps businesses determine their appropriate licensing solutions and apply for and obtain the requisite licenses and permits. We will ensure your registration applications are submitted in line with Health Canada regulations.
Remediation
Our team of experts will act as your liaison with Health Canada and apply our unique Q&C™ Remediation Navigator process to address concerns and observations efficiently and keep production running.
Training
We wrote the book on compliance and GMP and our team is passionate about sharing knowledge. We help you identify and deliver top training solutions for you and your team on-site, or virtually.
Customer Testimonials
THE POCKET-SIZED ON-THE-GO REFERENCE BOOKLET
The Red Book
Fully Updated with New Health Canada GMPs for APIs
GUI-0104, February 2022
Fully cross-indexed
Excellent training resource