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

Training

GMP Fundamentals 

Medical Device Fundamentals

ISO 13485:2016 MDSAP

Annual GMP Training

Preparing for a Regulatory Inspection

Quality Auditing

Good Documentation Practices

Importation / Establishment Licensing


Stuart du Kamp

Our Quality Assurance Consulting Leader 

Stuart du Kamp, Senior Director, QA GMP Services

Stuart du Kamp
In his present role as Senior Director, QA GMP Services, Stuart is responsible for the quality assurance oversight of Innomar’s 3PL, specialty and wholesale activities nationwide. Stuart also leads a team of seasoned quality assurance professionals providing consulting services across the full range of pharmaceutical platforms. Stuart brings over 30 years of experience in the pharmaceutical industry, including over 20 years in Quality Management, 12 years within CMO organizations, and specific experience within the API, sterile, biotechnology, pharmaceutical and medical device sectors. He has a demonstrated record of successfully melding quality compliance with business goals, leveraging his extensive expertise in quality risk management. Stuart has served on a number of industry working groups and has developed a reputation as an 'ideas' guy, and an innovator, who thrives in environments that demand pragmatic, cost effective and timely solutions to complex problems. 
Stuart du Kamp

Insight

Commercializing in Canada: Quality Assurance and GMP Services


Innomar Strategies
April 2020

Wondering what role quality assurance plays in the Canadian drug commercialization process? Ask us.

People meeting in a Boardroom