ACERNA Inc.orporated

Details ACERNA Inc.orporated ACERNA Inc.orporated

www.acerna.ca

Ontario

Toronto GTA

Markham

Corporation

active

Operating name: ACERNA Inc.



Good Manufacturing Practices/QSR services encompass: - Drug Good Manufacturing Practice audits and compliance
- Quality Assurance vendor audits
- 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 qualified Person In Charge of the quality control department
- Pre-approval inspections
Regulatory Affairs services include the preparation of: - 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
- Drug Master Files
Country of Ownership: Canada
Year Established: 1995
Exporting: Yes
Primary Industry (NAICS): 541690 - Other Scientific and Technical Consulting Services
Primary Business Activity: Services

Services:
Pharmaceutical, biological, natural health products, and medical device consultants

Technology:
ACERNA is especially knowledgeable of innovative medical
devices, pharmaceuticals, and biological products especially
sterile and ophthalmic products.

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Profile ID: LFCA-COD-O-16912