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Regulatory Compliance & Quality Management Services

Regulatory Affairs & Licensing

We manage complex licensing and product registrations to ensure swift market entry while meeting all regulatory expectations from the

start.

  • Drug Establishment Licence (DEL) applications and renewals — Health Canada

  • Medical Device Establishment Licence (MDEL) applications

  • Medical Device Licence (MDL) applications — Class I, II, III, and IV devices

  • Natural Health Product (NHP) Product Licence applications and post-market maintenance

  • NHP Site Licence applications and ongoing compliance management

  • Controlled Drugs and Substances Act (CDSA) Dealers Licence applications and compliance support

  • Cannabis Act and Regulations — licence applications, amendments, and ongoing compliance management

  • Import and Export Permit applications under CDSA and cannabis regulatory frameworks

  • Label compliance reviews and labelling guidance under the Food and Drug Act, NHPR, and Cosmetic Regulations

  • Regulatory strategy development for multi-jurisdictional submissions (Health Canada, FDA, EMA, TGA)

  • FDA cGMP compliance gap assessments and remediation planning for companies targeting the US market

  • ICH guideline compliance advisory services

Quality Management Systems

Our experts strengthen your QMS frameworks to significantly reduce compliance risk and streamline your operational workflows for long-term reliability.

  • QMS gap assessments, implementation planning, and full deployment for pharmaceutical, food, NHP, and cosmetics manufacturers

  • Quality Manual preparation, implementation and ongoing maintenance

  • SOP development, review cycles, change control, and periodic review management

  • Document control system design and configuration

  • Internal audit programs — scheduling, conduct, findings management, and CAPA follow-up

  • Out-of-Specification (OOS) investigation protocols and deviation management systems

  • Annual product review, quality reports, and KPI dashboard design

  • Trend analysis programs and continuous improvement frameworks

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Audit Preparation & Remediation

We prepare your facility for rigorous inspections to ensure you pass with confidence and sustain compliance through reduced findings.

  • Pre-inspection readiness assessments for Health Canada GMP, Cannabis Act, and FDA inspections

  • Mock audit execution, coaching, and debrief sessions

  • Audit finding response preparation — CAPA letters and formal inspection response packages

  • Remediation project management following regulatory findings or Warning Letters

  • Third-party supplier and vendor audit programs

  • Ongoing audit-ready facility maintenance programs

GMP Compliance Training

Equip your team with the essential knowledge to maintain high safety standards, directly improving outcomes during regulatory reviews.

  • GMP/cGMP training program design and delivery — onsite and virtual formats

  • Good Distribution Practices (GDP) training programs

  • Good Pharmacy Practices (GPP) training

  • HACCP training, implementation support, and documentation

  • SQF (Safe Quality Food) Systems training and implementation

  • Cannabis Act / Good Production Practices (GPP) training

  • Controlled substances awareness and safe handling training

  • Annual GMP refresher programs and training record management systems

Validation & Technical Engineering

Our technical mastery ensures your processes and equipment meet rigorous standards, minimizing operational downtime and compliance gaps.

  • Supplier qualification programs — documentation, questionnaires, and on-site audit support

  • Approved Supplier List (ASL) development and ongoing maintenance

  • Process validation — Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

  • Equipment qualification protocols and execution reports

  • Cleaning validation protocols and support

Analytical method validation guidance

Post-Market Vigilance

We Provide authoritative oversight on adverse event reporting to safeguard public health and ensure your sustained regulatory integrity.

  • Regulatory pathway assessment for new product development initiatives

  • Product dossier and regulatory submission preparation

  • Labelling design review for compliance with all applicable regulations

  • Stability program design and oversight support

  • Scale-up and technology transfer compliance support

  • Pre-submission meeting preparation and Health Canada liaison

  • Launch readiness compliance assessments

Our  Approach

At ReguGlobe, we follow a systematic four-step methodology to navigate complex regulations. This structured approach ensures we deliver reliable, long-term compliance outcomes for your business.

1. Assess

We begin by evaluating your current operations against regulatory requirements to identify specific gaps and compliance risks.

2. Plan

Our experts design a customized roadmap with clear milestones, prioritizing actions that ensure the fastest path to full compliance.

Consult Our Experts
3. Implement

We work alongside your team to deploy quality systems, prepare documentation, and execute necessary training for your workforce.

4. Sustain

We establish monitoring systems and post-market vigilance programs to ensure your regulatory status remains secure as your business grows.

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