GMP Training, DEL Application, QMS development, and Validation Studies for Drug Wholesaler

Client Type: Regulatory Submissions, Professional Training

Jurisdiction(s): Canada

Services Provided: Developed QMS per GMP standards. Worked with team to design QMN with adequate provisions for handling document change control and wholesale activities. Prepared and implemented GMP & SOP training and record keeping for personnel. DEL application based on products. DEL corrective/actions/Health Canada Response/licensing verification.