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PHARMACEUTICAL & BIOTECHNOLOGY SERVICES

Executive Operational & Compliance Support

OXC Consulting provides strategic operational support to pharmaceutical and biotechnology organizations across manufacturing, quality, regulatory, and data environments.

We specialize in building structured, compliant, and inspection-ready systems that support GMP-regulated operations, cross-functional coordination, and continuous process improvement.

From documentation architecture to manufacturing analytics, we help teams reduce risk, improve visibility, and strengthen execution across regulated environments.

MANUFACTURING
QC & ENGINEERING

Signing a Document

PURPOSE

The purpose of our Pharmaceutical & Biotechnology Services is to:

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  • Strengthen operational structure in regulated environments

  • Ensure documentation integrity and compliance alignment

  • Improve manufacturing and quality data visibility

  • Support inspection readiness and audit preparedness

  • Reduce operational risk through systemized processes

  • Enhance cross-functional collaboration between Clinical, Medical Affairs, Quality, Manufacturing, Regulatory, IT and Supply Chain teams

 

Our approach integrates compliance, data analytics, and operational discipline into practical systems that work in real-time production environments.

SCOPE OF WORK

May include, but is not limited to:

 

1. GMP Documentation & SOP Development

  • SOP authoring and revision

  • Controlled document lifecycle structuring

  • Work instructions and batch record alignment

  • Deviation and CAPA documentation support

  • Documentation remediation initiatives

 

2. Manufacturing & Data Analytics Support

  • KPI dashboard development

  • Deviation trend analysis

  • Pareto analysis and root cause categorization

  • OEE and production performance tracking

  • Temperature excursion and environmental monitoring analysis

  • MKT (Mean Kinetic Temperature) reporting

 

3. Quality & Compliance Support

  • Audit readiness preparation

  • Internal quality system reviews

  • Regulatory gap assessments

  • Data integrity assessments

  • 21 CFR Part 210 & 211 alignment

  • GDP documentation controls

 

4. Operational System Design

  • Access control mapping

  • Role-based permission structures

  • Process mapping & workflow design

  • Cross-site reporting structure alignment

  • Shared drive architecture & document governance

 

5. Project-Based Consulting

  • Launch support for new systems

  • Remediation projects

  • Manufacturing transfer documentation

  • Change control program setup

  • Technical writing for regulated environments

Abstract Blue Gradient

May include, but is not limited to:

 

REGULATORY ALIGNMENT

 

All work is structured to align with:

  • GMP (Good Manufacturing Practice)

  • GDP (Good Documentation Practice)

  • 21 CFR Part 210 & 211

  • US FDA regulatory expectations

  • EU regulatory frameworks

  • Japan PMDA considerations

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