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Other Capabilities

Not every challenge needs a full facility build or a full taskforce.

Consider a streamlined way to explore targeted, high-impact services—whether you’re stabilizing a QMS, releasing batches, or preparing for your next inspection.

When to Use These Services
Available Services
How These Fit

Other Capabilities

Modular GMP & Regulatory Services That Support, Stabilize, and Strengthen Your Operations

Not every challenge needs a full facility build or a retained taskforce.

This page offers a streamlined way to explore targeted, high-impact services—whether you’re stabilizing a QMS, releasing batches, or preparing for your next inspection.

When to Use These Services
Available Services
How These Fit

 

When to Use These Services:

This service is ideal if you are:

Need support with CQV, supplier audits, or interim QA/QC functions

Require batch release but don’t need full QP integration

Want help navigating Decree-Law compliance or EDE licensing

Are mid-project and need specialist intervention (validation, OpEx, QMS stabilization)

Are building internal capacity but need senior oversight now

 

Available Services

Grouped by domain—each can be delivered standalone or alongside your current projects.

Quality & Compliance Support

  • Commissioning, Qualification & Validation (CQV)
  • Batch Release & Certification
  • Quality Assurance (QA) & Quality Control (QC)
  • Supplier Audits & Vendor Qualification
  • Deviations, CAPAs, Change Controls
  • Risk Management & Data Integrity
  • Interim Quality Management
  • Inspection Readiness

Distribution, Warehousing & Release

  • EDE-compliant warehousing, importation & distribution setup
  • RP/QP coverage for local UAE operations
  • Product recall planning & regulatory notifications
  • Cold chain oversight, labeling & packaging compliance
  • Transportation licensing & release review

 

Regulatory Submissions & Market Access

  • Regulatory applications (UAE, EU, US)
  • Import/export licenses, warehousing approvals
  • Local Agent services for UAE compliance
  • Pharmacovigilance setup
  • Response drafting for Warning Letters, audit observations

Operational Services & Strategic Add-ons

  • Technical writing (SOPs, protocols, validation docs)
  • Staff training
  • Staff augmentation (QA, QC, validation, inspection, packaging specialists)
  • Lifecycle Management (product, process, systems)
  • Operational Excellence (OpEx) & Continuous Improvement
  • Project Management & Board Advisory
  • Due diligence for mergers, acquisitions, and site transfer

 

 

How These Fit:

These services are often used to:

Bridge internal team gaps

Support remediation timelines

Complement full facility delivery or GMP retainer structures

Demonstrate regulatory preparedness to investors or boards

 

 

 

 

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