Q&C
- Company typePrivate
- Founded1994
- HeadquartersMississauga, Canada
- Headcount51–100
- GTM typeB2B
- OfferingServices
Q&C firmographics
Firmographics- Name
- Q&C
- Legal name
- Quality & Compliance Services Inc.
- Website
- https://qualityandcompliance.com
- Company type
- Private
- Founded year
- 1994
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Ownership category
- akta.pro rank
Q&C industry classification
Industry- Product category
- Regulatory Compliance Consulting
- NAICS
- Other Scientific and Technical Consulting Services (54169)
- SIC
- Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)
- akta.pro primary industry
- Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ)
- akta.pro secondary industries
- Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH), Specialty Pharma & Biologics Distribution (GDP-compliant) (HLAGAMAD)
Keywords
Where Q&C is headquartered
LocationHeadquarters
- HQ city
- Mississauga
- HQ country
- Canada
- HQ region
- North America
Offices1 record
Markets served
Q&C business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Supply Chain, Technology or R&D, Infrastructure
Revenue model
- Regulatory Consulting Services: Professional consulting services including regulatory submissions, product evaluations, clinical trial applications, and facility licensing support for drugs, NHPs, and medical devices.
- GMP Consulting Services: Good Manufacturing Practices consulting including gap assessments, compliance remediation, audits, quality system setup, and ongoing quality assurance support.
- Importing Services: Full-service importing of regulated products under Q&C's own Health Canada licences, including product submissions, quality representative services, and Qualified Person responsibilities.
- Training Services: GMP and regulatory training delivered on-site, virtually, or at their offices. Includes courses on GMP compliance, pharmacovigilance, deviations management, and inspection readiness.
- GMP Booklet Sales: Sale of GMP reference booklets including The Green Book 2025 Edition, The RedBook, The BlueBook, and The PurpleBook. Some editions available as e-books.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Freemium | Pay-as-you-go | Free compliance and regulatory assessment tools |
| One time/ perpetual license | Pay-as-you-go | GVP Training Session |
| Subscription | Pay-as-you-go | Advanced GMP Training for Drug Importers (In-person) |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels7 records
Q&C product offering
Product offeringCore offering
Q&C Services provides regulatory affairs, GMP compliance, and importing consulting for Health Canada-regulated products, including pharmaceuticals, natural health products, and medical devices. The firm assists clients with Drug Establishment Licence (DEL), NHP Site Licence, and MDEL applications, GMP audits and remediation, regulatory submissions (NDS/ANDS/DIN/NPN/MDL), pharmacovigilance, and imports products under its own Health Canada licences via the Rapid Release Team™.
Product overview
Q&C Services is a full-service regulatory and GMP compliance consulting firm offering integrated consulting services rather than a unified software product. The portfolio comprises nine core consulting services: Audits, Expert Witness Consulting, Facility Licensing, GMP Consulting, Importing (with Rapid Release Team™), Pharmacovigilance Services, Regulatory Services, Remediation (Q&C™ Remediation Navigator), and Training. These services are delivered by over 60 full-time consultants and work together to provide end-to-end support for regulated products in Canada. The company also publishes four industry-standard GMP reference booklets—The Green Book™ (NHP GMP), The RedBook™ (API GMP), The BlueBook™ (GUI-0001), and The PurpleBook™ (Medical Devices)—which complement the consulting services and serve as training materials. Q&C operates as Canada's largest independent full-service regulatory consultant, using its own Health Canada licences (DEL, NHP Site Licence, MDEL) to import products on behalf of clients.
Differentiator
Problem solved
Functional benefit
Brands
- Rapid Release Team™: Team that facilitates faster and simpler product release for importing into the Canadian marketplace.
- Q&C™ Remediation Navigator
Products and services
- Audits Internal and pre-regulatory GMP audits for pharmaceutical, NHP, and medical device companies, including self-inspections, GVP inspections, GMP evidence audits, vendor qualification, infusion clinic audits, and due diligence audits.
- Expert Witness Consulting Expert witness and analysis services for legal proceedings involving GMP compliance and pharmaceutical regulatory matters, supporting legal teams in building the strongest possible case.
- Facility Licensing Assistance with Drug Establishment Licence (DEL), NHP Site Licence, and Medical Device Establishment Licence (MDEL) applications, maintenance, amendments, and renewals in Canada.
- GMP Consulting Good Manufacturing Practice compliance consulting including Health Canada remediation, phased GMP for drug development, backlog resolution, fractional VP/quality services, quality system restructuring, data integrity, and software validation.
- Importing (Rapid Release Team™) Full-service importing of drugs, NHPs, and medical devices into Canada under Q&C's own Health Canada licences, with the proprietary Rapid Release Team™ accelerating time-to-market.
- Pharmacovigilance (PV) Services Expert guidance on pharmacovigilance strategies, periodic safety update reports, adverse event reporting, signal detection, risk management plans, and GVP compliance for pharmaceutical clients.
- Regulatory Services Comprehensive regulatory support including product evaluation, submissions (NDS, ANDS, DIN), CPP certificates, medical device licensing, NHP applications, clinical trial applications, label reviews, and DEL gateway.
- Remediation (Q&C™ Remediation Navigator) Structured four-stage remediation service (Remediation Triage, Compliance Strategy, Quality Advantage, Trusted Advisor) to address Health Canada concerns, observations, and license-jeopardy situations efficiently.
- Training GMP and regulatory compliance training delivered on-site, virtually, or at Q&C offices in Mississauga, with off-the-shelf or customized courses for pharmaceutical, NHP, and medical device professionals.
- The Green Book™ GMP reference booklet for Natural Health Products covering Health Canada's GUI-0158 guidance, pocket-sized, updated 2025 edition.
- The RedBook™ GMP reference booklet for Active Pharmaceutical Ingredients (APIs) covering ICH Q7 requirements, updated February 2022.
- The BlueBook™ Industry standard GMP reference booklet covering GUI-0001, updated 2020, recognized as the standard for GMP compliance in Canada and the U.S.
- The PurpleBook™ GMP reference booklet covering Medical Device Regulations for the Canadian market.
Quantifiable outcome
- Achieved compliant rating within 12 months for a company that received non-compliant rating, and maintained compliant status every year since
- +3 more outcomes
Companies that use Q&C
Customer profileNamed customers6 records
Segments5 records
Ideal customer profiles2 records
Q&C technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Q&C partnerships and signals
Strategic signalScale indicators10 records
Recent moves6 records
Expansion highlights6 records
Q&C competitors and assessment
Company assessmentDirect peers
- PharmaLex (now part of Cencora): PharmaLex (acquired by Cencora/World Courier) is a regulatory affairs and quality compliance consulting provider for pharma and biologics, offering outsourced QP/RP and audit services that overlap directly with Q&C's GMP and quality representative offerings.
- ProPharma Group: ProPharma Group is a global regulatory, compliance, and pharmacovigilance consulting firm for pharma, biotech, and medical device companies — directly comparable to Q&C's outsourced quality, regulatory, and PV services portfolio across multiple regulatory jurisdictions.
- APCER Life Sciences: APCER provides regulatory, pharmacovigilance, and quality compliance consulting to pharma and medical device companies — directly comparable in scope to Q&C's regulatory, PV, and GMP service offerings.
- Voisin Consulting Life Sciences (VCLS): VCLS is a regulatory and quality consulting firm serving biotech, pharma, and medical device developers — directly comparable in GMP, clinical, and product registration advisory services to Q&C's regulatory and quality portfolio.
- Biologics Consulting Group (now Veristat): Biologics Consulting (now operating under Veristat) provides regulatory and product development consulting with strong GMP expertise — closely mirroring Q&C's focus on biologics, drug, and device regulatory pathways.
- Halloran Consulting Group: Halloran provides regulatory, quality, and clinical consulting to life sciences companies — closely matching Q&C's GMP consulting, audits, and remediation offerings for emerging and mid-sized pharma and device firms.
- The FDA Group: The FDA Group is a regulatory and quality consulting firm serving pharmaceutical, medical device, and biotech companies with audits, remediation, and compliance services — a direct comparable to Q&C's audit and GMP consulting business.
Broad incumbents
- ICON plc: ICON offers regulatory, pharmacovigilance, and quality consulting services as part of a broad CRO portfolio — a broader incumbent competing for the same enterprise clients Q&C serves in pharma and biologics.
- Parexel International: Parexel is a large CRO offering regulatory affairs, GMP consulting, and pharmacovigilance services globally — overlapping with Q&C's service lines but at much broader scale and across multiple regulatory regimes including FDA, EMA, and Health Canada.
- IQVIA: IQVIA is the world's largest CRO with extensive regulatory affairs and quality compliance consulting practices — competing with Q&C on enterprise regulatory mandates for the largest pharma clients across multiple geographies.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Q&C social profiles
Digital presenceQ&C compliance and trust
Trust signalCompliance5 records
Q&C financial estimates
Financial estimateRevenue estimate
Valuation estimate
Q&C leadership team
Management profileNumber of profiles
Profiles6 records
Q&C funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Q&C M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Q&C
What does Q&C do?
Q&C Services provides regulatory affairs, GMP compliance, and importing consulting for Health Canada-regulated products, including pharmaceuticals, natural health products, and medical devices. The firm assists clients with Drug Establishment Licence (DEL), NHP Site Licence, and MDEL applications, GMP audits and remediation, regulatory submissions (NDS/ANDS/DIN/NPN/MDL), pharmacovigilance, and imports products under its own Health Canada licences via the Rapid Release Team™.
Is Q&C a public or private company?
Q&C is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Q&C founded?
Q&C was founded in 1994. It employs 51 to 100 people.
Where is Q&C based?
Q&C is headquartered in Mississauga, Canada, in the North America region.
How does Q&C make money?
Five revenue lines are on record. Regulatory Consulting Services are the primary driver. The others are GMP Consulting Services, importing Services, training Services and GMP Booklet Sales.
Who are Q&C's main competitors?
Direct peers on record are PharmaLex (now part of Cencora), ProPharma Group, APCER Life Sciences, Voisin Consulting Life Sciences (VCLS), Biologics Consulting Group (now Veristat), Halloran Consulting Group and The FDA Group. Broad incumbents are ICON plc, Parexel International and IQVIA.
Does Q&C have an API?
No public API is recorded for Q&C.
What industry is Q&C in?
Q&C's product category is Regulatory Compliance Consulting. Its primary akta.pro industry code is HLAGAKAJ, Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA), with a secondary code of HLAGAKAO, Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent). Its NAICS code is 54169 and its SIC code is 5122.