quality assurance
In the highly regulated Biotech, Medical Device and Pharmaceutical Industries, all operations are governed by quality assurance policies and procedures . . .
thus, they need to be expertly designed.
CDS can build the right quality system to anchor your unique organizations’ operations.
The CDS Quality Assurance Team
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 less errors, less wasted time, fewer wasted materials, and ultimately, money saved.
CDS Quality Consulting Services are comprised of:
Development and Implementation of GMP Compliant Quality Systems for Biotech, Pharmaceutical and Medical Device companies
o Prepare and maintain Standard Operating Procedures (SOPs)
o Host compliance (GMP) inspections by FDA and Health Canada
o Batch Record review and product release as Quality Control
o Manage finished product release and stability testing
o 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.