Quality Assurance

Our Quality Assurance Team

CDS can build the right quality system to anchor your unique organizations’ operations. Our team provides expert design in line with regulated quality assurance policies and procedures.

The CDS quality assurance team possesses years of robust industry experience. We build functional, reliable systems for our pharmaceutical, biotechnology, and medical device clients.

As a result, CDS clients boast:

A reduction in errors

Green checkmark inside a blue square on a white background

Improved efficiency and project timelines

A check mark inside a blue square on a white background.

Fewer wasted materials

A green check mark inside a blue square.

Cost savings

A checkmark inside a square, indicating a positive or completed status.

CDS Quality Consulting Services

  • Development and Implementation of GMP Compliant Quality Systems for Biotech, Pharmaceutical and Medical Device companies

    • Prepare and maintain Standard Operating Procedures (SOPs)

    • Host compliance (GMP) inspections by FDA and Health Canada

    • Batch Record review and product release as Quality Control

    • Manage finished product release and stability testing

    • Prepare and maintain product technical dossiers

  • Third Party Audit services, as well as subsequent gap analyses:  Good Manufacturing Practice (GMP) inspections to ensure that relevant Health Canada and/or FDA requirements are met

  • Prepare Technical Quality Agreements

  • Manage or assist with Inspections and Audits from Start to Close-out including:

    • Health Canada

    • FDA

    • Third Party Vendor Audits

    • Internal Self-Inspections

Quality Assurance for Clinical Trials

Collaborating with our Clinical Trial Team, CDS QA staff can provide the support to ensure a high calibre study with meaningful results. 

Clinical Trial Quality Services at CDS: 

  • Audit clinical trial sites and clinical trial systems to assess compliance with ICH-GCP and recommend steps to improve processes, develop your SOPs, and train your staff.

  • With extensive ICH-GCP expertise, assess needs and develop a full SOP system or modernize your current system to assist your staff in conducting efficient trials and satisfy international regulatory requirements.

  • Sponsor & Clinical Trial Site Staff Training: assess staff training requirements, then develop and conduct training tailored to those specific needs and objectives.

Ready to experience the CDS Difference?

Get in touch with our team to see how we can meet your organization’s needs.