ACERNA Inc.
Good Manufacturing Practices/QSR services encompass:
- American & Canadian Drug Good Manufacturing Practice
audits and compliance
- Good Laboratory Practice audits
- Quality Assurance vendor audits
- FDA medical device Quality System Regulation audits
- GMP & QSR training
- Advice on Quality Control Laboratory Practices and
Method Validation
- Consulting on manufacturing systems including purified
water systems
- Consultants on sterile product manufacturing and
quality control
- Development of process validation protocols
- Functioning as the responsible Canadian quality
control department
- Pre-approval inspections
Regulatory Affairs services include the preparation of Canadian:
- Clinical Trial Applications
- New Drug Submissions
- Abbreviated New Drug Submissions
- Supplemental Submissions
- Drug Identification Number Applications
- Medical Device submissions
- Provincial formulary submissions
- Site Licences
- Establishment Licences
- Product Licences
Company Details
Year Established:
1995
Company Information
Paul Larocque
Title:
President
Area of Responsibility:
Management Executive
Telephone:
(905) 472-5747
Email:
Click Here
Services
Pharmaceutical, Biological, And Medical Device Consultants