Embelton Pharma Services

1) Regulatory Affairs & Product Registration

Embelton Pharma Services helps international pharmaceutical, biotech, and medical device companies successfully enter and expand across the Middle East and Africa (MEA). We combine global regulatory expertise with strong local authority knowledge to ensure compliant market entry.

Our Goal: Simplify regulatory complexity and enable confident MEA market access.

Our Services

Regulatory Strategy

Market entry planning & roadmap

• Market entry pathways and regulatory planning
• Gap analysis aligned with ICH, FDA & EMA
• Approval strategy & timeline forecasting

Dossier & Submissions

End-to-end dossier management

• CTD / eCTD / ACTD preparation
• Country-specific regulatory dossiers
• ANDA & DMF submission support

Product Registration & Licensing

Authority approvals & permits

• Marketing Authorization Applications
• Import & manufacturing licenses
• Regulatory follow-up with authorities

Post-Approval Support

Lifecycle compliance management

• Deficiency & query response handling
• Variations, renewals & amendments
• Pharmacovigilance documentation support

Market Access Support

Commercial & regulatory alignment

• Pricing & reimbursement guidance
• Local regulatory representation
• Post-market compliance & reporting

Why Embelton Pharma Services

What sets us apart

• Global standards applied locally
• Experienced regulatory professionals
• Efficient & practical execution
• End-to-end lifecycle support

Who We Support: International pharma & biotech companies, regional license holders, distributors, and organizations entering MEA markets for the first time.

2) GMP Audit Services

Your Partner for Compliance, Quality, and Data Integrity

Specialized Gap Audits & Supplier Due Diligence

At Embelton Pharma Services, we help pharmaceutical companies ensure their suppliers, manufacturing, and packaging operations meet the highest standards of quality, compliance, and data integrity. Our team of North American and Canadian experts brings decades of industry experience to every audit.

Our Services & Methodology

How we ensure GMP compliance

We provide a structured approach to ensure comprehensive compliance:

• Gap Assessment: Identify gaps against global GMP standards.
• Mock Inspection: Simulated FDA, HC, WHO & EU inspections.
• Supplier Qualification: Supplier quality & compliance evaluation.
• CAPA: Actionable corrective & preventive action plans.

Standards & Guidelines

Global regulatory alignment

• WHO GMP – World Health Organization
• ICH Q7 – GMP for APIs
• FDA 21 CFR 210 & 211
• Health Canada GMP (GUI-001)
• EU GMP – EudraLex Volume 4

Why Choose Embelton Pharma Services?

Our competitive advantage

• Expert Team: FDA, HC, EU & WHO experienced auditors.
• Data Integrity Focus: Accuracy & compliance first.
• Standards-Driven: Fully GMP aligned audits.
• Flexible: On-site & remote audits available.

3) Training and Capability

🎓 Training Excellence Through Canadian Partnerships
®GXPedia – Global GMP & GxP Training Platform

®GXPedia delivers globally recognized pharmaceutical training through partnerships with established Canadian institutions and senior industry experts. All programs are designed to meet international GMP and GxP standards and deliver regulatory-grade competence.

Canadian Institutional Partnerships

Under the ®GXPedia platform, Embelton Pharma Services delivers advanced pharmaceutical training in collaboration with well-established Canadian pharmaceutical institutions.

• Scientifically rigorous programs
• Aligned with international GMP and GxP requirements
• Delivered using current industry best practices

All ®GXPedia curricula are designed, governed, and quality-controlled in Canada, and delivered by internationally recognized subject-matter experts with real regulatory and industry experience.

Training Delivery Model

Curriculum Design & Governance

• Developed and approved in Canada
• Aligned with Health Canada, FDA, and EU GMP frameworks

Delivery Modes

• Online instructor-led training
• Client on-site training
• Canadian training institute facilities

Programs are delivered by senior pharmaceutical professionals, former regulators, and experienced GMP practitioners.

Regional Capability Building

• Tailored for Middle East & Africa (MEA) regulatory environments

Why ®GXPedia

• Builds confidence with Ministries of Health and regulators
• Supports inspection readiness and sustainable compliance
• Develops audit-defensible competencies
• Strengthens eligibility for tenders and partnerships
• Focuses on practical application—not theory

Our Training Philosophy

®GXPedia programs go beyond classroom learning. Training is focused on real inspection expectations, compliance decision-making, and operational excellence— delivered online, on-site, or in Canada.

®GXPedia — Global GMP & GxP Training. Governed in Canada. Delivered Worldwide.

®GXPedia | Regulatory Affairs Training Regulatory Intelligence. Market Access. Compliance.

Practical training covering the full regulatory lifecycle—from product development and registration to post-approval changes.

Key Topics

• Global regulatory frameworks (Health Canada, FDA, EMA, WHO)
• CTD / eCTD submissions
• Variations, renewals, and lifecycle management
• Regulatory strategy for generics, biosimilars, and innovation
• Authority interactions and inspection responses

Delivery Modes: Online | Client Site | Canadian Training Institute
Outcome: Regulatory-ready professionals supporting successful approvals.

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®GXPedia | Quality Assurance (QA) Training Inspection-Ready Quality Systems .

Focused on building and maintaining effective Pharmaceutical Quality Systems aligned with global GMP.

Key Topics

• GMP compliance and advanced QA practices
• ICH Q10 Pharmaceutical Quality Systems
• Deviations, investigations, and CAPA
• Change control and quality risk management (ICH Q9)
• Audit readiness and data integrity

Delivery Modes: Online | Client Site | Canadian Training Institute
Outcome:Sustainable GMP compliance and improved inspection outcomes.

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®GXPedia | Quality Control (QC) Training Analytical Excellence. Data Integrity. Compliance.

Hands-on and practical training for GMP laboratory and analytical operations.

Key Topics

• GMP laboratory operations
• Method validation and lifecycle management
• OOS, OOT, and lab investigations
• Data integrity (ALCOA+)
• Stability programs and inspections

Delivery Modes: Online | Client Site | Canadian Training Institute
Outcome:Reliable, inspection-defensible laboratory data.

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®GXPedia | Pharmacovigilance Training Patient Safety. Regulatory Compliance.

Training aligned with global drug safety and reporting requirements.

Key Topics

• Global PV regulations (HC, FDA, EMA, ICH, WHO)
• Adverse event processing and reporting
• Risk Management Plans (RMPs)
• PV audits and inspections
• Product recalls and safety communications

Delivery Modes: Online | Client Site | Canadian Training Institute
Outcome:Inspection-ready pharmacovigilance systems.

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®GXPedia | Pharmaceutical Sales & Marketing Training Compliant Promotion. Market Success.

Bridging commercial effectiveness with regulatory and ethical compliance.

Key Topics

• Promotional compliance and ethical marketing
• Claims substantiation and medical information
• HCP interactions
• Market access, tenders, and distributor oversight
• MEA regulatory and cultural considerations

Delivery Modes: Online | Client Site | Canadian Training Institute
Outcome:Commercial success supported by compliant practices.

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4) Business Development / In-Licensing

Access the MEA Pharmaceutical Market – Iraq & Syria Focus

A Canada-based market access partner for international pharmaceutical manufacturers. The Middle East & Africa (MEA) region offers strong demand growth for essential, specialty, and hospital pharmaceuticals—but entry into markets such as Iraq and Syria requires careful regulatory coordination, distributor governance, and risk management.

We help international pharmaceutical manufacturers enter and operate in MEA markets, with a structured focus on Iraq and Syria, through a compliant, asset-light, and partner-driven market access model.

Our Role

We act as your regional market access and commercialization coordination partner. From our Canadian base, we coordinate:

• In-licensing and commercialization frameworks
• Regulatory strategy and country-specific registration coordination
• Distributor identification, appointment, and governance
• Ongoing compliance, documentation, and commercial oversight

You focus on manufacturing and supply. We manage structured MEA market entry.

Focus Markets: Iraq & Syria

• Coordination with licensed Iraqi scientific bureaus
• Structured MOH registration and lifecycle management
• Distributor governance with performance KPIs
• Strong demand across retail, hospital, and tender channels

We design market entry strategies specific to each jurisdiction — not one-size-fits-all.

How We Support Manufacturers

In-Licensing & Market Structuring

Commercial & regulatory framework design

• Country scope and territorial rights definition
• Commercial and supply responsibility structuring
• Clear regulatory and compliance role allocation

Manufacturers enter MEA markets without establishing local legal entities.

Regulatory Coordination

End-to-end authority engagement

• Preparation and submission of registration dossiers
• Health authority correspondence, renewals & variations
• Coordination of regulatory timelines and country-specific requirements

Distributor Selection & Governance

Performance & compliance control

• Defined exclusivity or territory scope
• Sales targets and reporting KPIs
• Pharmacovigilance and compliance obligations
• Replacement and termination rights

Quality & Compliance Governance

GMP & ongoing oversight

• Manufacturer qualification & GMP documentation review
• Alignment with local regulatory expectations
• Ongoing compliance oversight through partner governance

Why Manufacturers Use This Model

• Lower regulatory and compliance exposure
• No local entity requirement
• Improved control over distributors
• Scalable across multiple MEA markets
• Structured approach to complex jurisdictions

What We Don’t Do

• Manufacture pharmaceutical products
• Perform laboratory testing or batch release
• Operate warehouses or logistics
• Act as a local distributor

Our role is coordination, governance, and execution — not trading.

A Smarter Way into MEA

We are not a distributor. We are not a broker. We are a market access platform designed to help manufacturers enter difficult markets safely, maintain visibility and control, and build a sustainable MEA presence.

Canadian coordination. Local execution. Compliance-first by design.

Let’s Discuss Your MEA Strategy

If you are evaluating entry into Iraq or Syria, restructuring an existing MEA distributor network, or launching a targeted portfolio in complex markets — let’s talk.

Contact us to discuss a structured, compliant path into the MEA region.

5) Digital Transformation Support

Expert Consulting in Smart Factory, MES, and Digital Transformation

Unlock Operational Excellence with Proven Methodology

Embelton Pharma Services helps pharmaceutical companies transform operations through Smart Factory solutions, MES systems, and digital innovation. Our experts bring global compliance experience from North America, Europe, and beyond.

Our Methodology

Supplier Qualification → Gap Assessment → Implementation Strategy → Deployment → CAPA

A structured approach to ensure your operations are audit-ready, compliant, efficient, and designed to reduce human errors.

What We Offer

MES Consulting: From design to validation, we ensure your MES meets operational needs and regulatory standards while minimizing manual interventions.

Why Choose Us

• Industry Expertise: Experienced in MES quality operations across pharmaceutical manufacturing and packaging.
• Regulatory Compliance: Solutions aligned with GMP, FDA, EMA, and WHO, emphasizing data integrity.
• Continuous Improvement: CAPA-driven follow-up ensures sustainable compliance, performance, and error reduction.