ACERNA Inc.
Markham, ON
Company Overview
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 Information
Physical Address
19 Bryant Rd
Markham, ON L3P 5Y7
CA
Mailing Address
19 Bryant Rd
Markham, ON L3P 5Y7
CA
Additional Details
Legal Name: ACERNA Inc.
CA
ACERNA is especially knowledgeable of innovative medical devices, pharmaceuticals, and biological products especially sterile and ophthalmic products.
Contacts
Paul Larocque
Title: President
Area of Responsibility: Management Executive
Phone: Show phone
Email: Show email
Services
- Pharmaceutical, Biological, And Medical Device Consultants
Additional Information
541690
G009-Other Health Services
Australia, Austria, Belgium, Denmark, Finland, Iceland, Ireland, Republic of (EIRE), Japan, Luxembourg, Netherlands, Norway, Sweden, Switzerland, United Kingdom, United States, Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming
Brazil