Release/ Reject Procedures

MCS Associates are qualified professionals with Canadian accreditation and have to served companies conducting licensable activities.

One important aspect of any Quality Program is the review of documentation related to a regulated product. MCS Associates Inc. are highly skilled in this area. and often write Standard Operating Procedures for many companies.

We also assist with the construction of any Release/Reject Program that allows companies to have Quality Control for their batches to ensure that manufacturer produces the Finished Product according to Specifications. This ensures that the Finished Product adheres to the requirements of the formulation. MCS conducts inspections and annual product reviews

Our Release/Reject program has been successfully implemented in companies across Canada and the U.S. Our senior regulatory consultants to the industry will visit your operations several times per year to insure that your regulatory documentation is up-to-date, accurate, and organized for compliance with Canadian Health Regulations.

MCS Associates comprehensive Release/Reject Program enables us to act on your behalf to produce and maintain documentation that will keep your operations GMP compliant.

Quality Assurance is a wide ranging service

  • Stability - Shelf Life - On-Going Stability Program
  • Post-Market Surveillance – Adverse Event Reporting
  • Overall approach to product quality control and risk management
  • Process – Sanitation – Health & Hygiene

Stamp of Approval Regulatory Affairs is a highly specialized discipline that often involves expertise from many different disciplines.

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Quality Assurance Covers:
  • Premises
  • Equipment
  • Personnel
  • Sanitation
  • Personnel
  • Raw Material testing
  • Packaging Material
  • Manufacturing Control
  • Recall
  • Self Inspection
  • Compliance of Contractors
  • Samples
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