Quality Assurance Consulting
Identifying effective solutions to complex problems
From importation, routine quality oversight and quality system development, to audit mitigation, training and facility validation; Innomar specializes in identifying effective solutions to complex problems. We can help you build a quality system that is right for you, and will allow you to effectively navigate the ever changing world of quality compliance.
We have multi-jurisdictional quality expertise in the following sectors:
Active Pharmaceutical Ingredients (APIs)
Pharmaceuticals
Biologics
Medical Devices (ISO 13485, MDSAP)
Natural Health Products
Cosmetics
Quality Assurance and Compliance Services
Compliance
- Quality Investigations (Deviations, OOS, CAPA, Complaints, etc.)
- Health Canada / FDA Remediation
- Quality Assurance Gap Analysis
- Internal Audits / Self Inspections
- Product Release
- Vendor Qualification (Suppliers, QC Laboratories, etc.)
- Backlogs (Batch Records, Deviations, Change Controls, Complaints, etc.)
- Quality System Development
- Quality Agreements
- APQR / YBPR Preparation
Audits
- 21 CFR Part 210 & 211 (FDA GMPs)
- Health Canada GMPs (Drug, Device, NHP)
- Health Canada GPPs (Cannabis)
- Medical Devices (ISO 13485 MDSAP)
- Fabricators (Pharmaceuticals, Biologics, APIs, Devices)
- Quality Control Laboratories
- Packagers / Labelers
- Distribution / 3PL
- Importers
Importation
- Act as a company’s QC Unit
- Establishment Licensing Application and Amendments
- Importer of Record Services
- Host Health Canada GMP Inspections
Validation
- Temperature Mapping
- Shipping Validation
- Facility / Equipment Validation
- Validation Protocol / Plan Development
