Q&C
Consultancy specializing in Canadian regulatory compliance, GMP consulting, importing and market entry for pharmaceuticals, natural health products and medical devices. Provides audits, facility licensing, pharmacovigilance, remediation, training and regulatory submission support, with specific expertise in Health Canada requirements and three decades of industry experience.
Industries
Nr. of Employees
medium (51-250)
Products
Demystifying Natural Health Product Regulations (NHP guide)
Guide to importing natural health products into Canada, covering classification, importing steps and case studies.
The Blue Book (GMP Guide GUI-0001)
Pocket reference covering GMP guidance aligned to GUI-0001.
The Green Book (GMP Guide for Natural Health Products)
Pocket-sized GMP guide for the Natural Health Products sector (2025 edition available).
The Red Book (GMP for APIs)
Reference guide covering GMP regulations for active pharmaceutical ingredients and ICH Q7 topics.
The Purple Book (Medical Device Regulations)
Pocket reference covering medical device regulatory and quality requirements.
Demystifying Natural Health Product Regulations (NHP guide)
Guide to importing natural health products into Canada, covering classification, importing steps and case studies.
The Blue Book (GMP Guide GUI-0001)
Pocket reference covering GMP guidance aligned to GUI-0001.
The Green Book (GMP Guide for Natural Health Products)
Pocket-sized GMP guide for the Natural Health Products sector (2025 edition available).
The Red Book (GMP for APIs)
Reference guide covering GMP regulations for active pharmaceutical ingredients and ICH Q7 topics.
The Purple Book (Medical Device Regulations)
Pocket reference covering medical device regulatory and quality requirements.
Services
Audit planning and execution for GMP, GVP, vendor qualification, evidence audits and clinical/infusion clinic audits.
Preparation and maintenance of DEL, MDEL and NHP Site Licence applications, renewals, amendments and foreign site assessments.
Import products under existing Canadian licences or add products to importer licences; manage importer responsibilities and logistics.
Preparation and submission of drug, device and NHP dossiers (eCTD/CTD), clinical trial applications and post-market amendments.
PV system implementation and management, PSUR/ASR preparation, signal detection, RMPs, adverse event reporting and PV audits.
GMP compliance programs, remediation navigator process, interim quality leadership, process validation and backlog resolution.
Audit planning and execution for GMP, GVP, vendor qualification, evidence audits and clinical/infusion clinic audits.
Preparation and maintenance of DEL, MDEL and NHP Site Licence applications, renewals, amendments and foreign site assessments.
Import products under existing Canadian licences or add products to importer licences; manage importer responsibilities and logistics.
Preparation and submission of drug, device and NHP dossiers (eCTD/CTD), clinical trial applications and post-market amendments.
PV system implementation and management, PSUR/ASR preparation, signal detection, RMPs, adverse event reporting and PV audits.
GMP compliance programs, remediation navigator process, interim quality leadership, process validation and backlog resolution.
Expertise Areas
- Health Canada regulatory compliance and market entry
- GMP and cGMP compliance and remediation
- Importation and importer-of-record services for Canada
- Pharmacovigilance and safety reporting
Key Technologies
- eCTD electronic submissions
- Quality Management Systems (QMS) frameworks
- Electronic records and e-signature/cloud storage systems
- Enterprise Resource Planning (ERP) systems
News & Updates
In-person advanced GMP course for quality personnel at drug importers focusing on inspection readiness, risk management and continuous improvement.
Executive team attending BIO-Europe to discuss Canadian market entry and compliance for pharmaceuticals.
Webinar addressing industry questions about updated NHP GMP guidance and implications for compliance.
In-person advanced training session on identifying, investigating and resolving deviations under Health Canada GMPs with emphasis on importer responsibilities.
Team attending BIO International Convention to engage with global life-science companies on regulatory strategies and Canadian market entry.
Webinar analyzing Health Canada inspection results and frequently cited GMP deficiencies based on internal inspection data.
In-person advanced GMP course for quality personnel at drug importers focusing on inspection readiness, risk management and continuous improvement.
Executive team attending BIO-Europe to discuss Canadian market entry and compliance for pharmaceuticals.
Webinar addressing industry questions about updated NHP GMP guidance and implications for compliance.
In-person advanced training session on identifying, investigating and resolving deviations under Health Canada GMPs with emphasis on importer responsibilities.
Team attending BIO International Convention to engage with global life-science companies on regulatory strategies and Canadian market entry.
Webinar analyzing Health Canada inspection results and frequently cited GMP deficiencies based on internal inspection data.