Our

Life Sciences

We partner with pharmaceutical, biotechnology, and medical device companies to accelerate innovation, ensure compliance, and deliver safe, effective solutions. From R&D to regulatory affairs and manufacturing, we provide specialized consulting expertise that drives success across the life sciences value chain.

Pharmaceutical

The pharmaceutical industry is transforming at lightning speed—and we stand at the forefront of that change. Our strength lies in combining deep scientific expertise with regulatory precision, enabling companies to move confidently from concept to commercialization. Whether it’s advancing R&D, ensuring regulatory compliance, strengthening quality frameworks, optimizing operations, or building resilient supply chains, our consultants deliver hands-on solutions that keep your business competitive in a tightly regulated, ever-evolving market.

Biotechnology

Biotechnology is where innovation meets impact, and our team thrives on navigating its complexities. From early-stage research and development through clinical trials, regulatory submissions, and post-market surveillance, we bring specialized knowledge that empowers companies to scale breakthroughs responsibly and sustainably. Our consultants help clients embrace cutting-edge technologies, adapt to evolving regulatory landscapes, and accelerate pathways to market—driving long-term value while ensuring patient safety and compliance.

Medical Devices

In the medical device and IVD sector, precision and compliance are non-negotiable. Our consultants combine global regulatory expertise, engineering know-how, and operational excellence to help manufacturers streamline processes and bring safe, effective products to market faster.

Core Capabilities

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Manufacturing

  • Person - in Plant Support
  • Production & Process Development
  • Supply chain / Supplier Controls
  • Technology Transfer
  • Process Validation (PV)
  • Cleaning Validation
  • Regulatory Affairs
  • EU MDR & IVDR
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Regulatory Affairs

  • EU MDR & IVDR
  • International Submissions
  • International Standards & Regulations
  • Post Market Support
  • Strategy
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Research & Development

  • Analytical Chemistry
  • Design Specification Development / Review
  • Mechanical & Electrical Engineering
  • Product Development
  • Technical Transfer & Scale Up
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Controls & Automation

  • PLC Programming
  • DCS Programming
  • SCADA
  • HMI Programming
  • Robotics Programming
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Quality Assurance

  • QMS Transformation
  • Risk Assessment / Analysis / Management
  • Regulations & Standards Compliance
  • Post Marketing, CAPA & Nonconformance
  • Change Control
  • Computer System Validation (CSV)
  • Equipment & Utility Validation
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Laboratory Services

  • Quality Assurance
  • Quality Control
  • Cell & Gene Therapy
  • Microbiology & Molecular Biology
  • Chemistry
  • Production Operations
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Cloud Technology

  • Amazon Web Services (AWS)
  • Microsoft Azure
  • Google Cloud
  • Oracle Cloud
  • IBM Cloud
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Artificial Intelligence

  • Computer Vision
  • Natural Language Processing (NLP)
  • Robotics & Intelligent Automation
  • Speech Recognition
  • Virtual Reality
  • Surveillance
  • Digital Twin
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Post Market

  • Complaint Management
  • Audit & Inspection Readiness
  • Risk Mitigation
  • Surveillance
  • Remediation
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IoT

  • Device / Sensor Programming
  • Connectivity / Network
  • Edge Computing
  • Regulatory Compliance
  • Application / User Interface
  • Secure Communications
  • API Design, Automation & Testing
  • Verification & Validation
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Enterprise Applications

  • SAP
  • Oracle
  • Workday
  • Dynamics365 (D365)
  • PeopleSoft
  • JD Edwards
  • Infor (S3 / M3 / Syteline)
  • NetSuite
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Supply Chain

  • Supplier Audits
  • Supplier Controls
  • Specification Development
  • Inventory Control
  • Systems & Infrastructure
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Quality & Control

  • Test Method
  • Investigation
  • Microbiology
  • Stability
  • Product Testing
  • Analytical Method Validation
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Validation Services

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Manufacturing

  • Process Validation (PV)
  • Cleaning Validation
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Quality Assurance

  • Computer System Validation (CSV)
  • Equipment & Utility Validation
  • Facility Qualification (IQ/OQ/PQ)
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Quality Control

  • Analytical Method Validation
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Laboratory Services

  • Label Instrument Validation
  • Process Validation (PV)
  • Cleaning Validation