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Staff Augmentation Services - Research & Development

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Pharma-Tech Process and Facilities Services, LLC provides technical support services to Research & Development operations at every stage of the product lifecycle.  Our project management, technical service personnel and scientist can identify project efficiencies to streamline clinical trials and regulatory filings. Our expertise in large scale biopharmaceutical cGMP manufacturing operations, technology transfer, single-use disposable technology, validation and compliance requirements allow us to develop fast-track product lifecycle programs and strategies for the development of biologic and medical drug products.

 

Pharma-Tech R & D capabilities include:

  • Project Management Best Practices
  • R&D Subject Matter Expertise (SME)
  • Cross-Functional Communication
  • Organization Development
  • Operational Excellence
  • Information Technology
  • Owners Representation
  • Implementation Strategies and Critical Path Development
  • Technical Writing
  • Investigational Studies, Protocols, Reports and Presentations
  • IND Documentation
  • Statistical Analysis
  • Formulation and Process Evaluation
  • Product Validation
  • Process Validation
  • Equipment Qualification
  • Method Development and Qualification
  • Technology Transfer
  • User Requirements
  • Criticality and Impact Assessment
  • Risk Assessment and Mitigation
  • Standard Operating Procedures (SOPs) and Guidelines
  • Change Control and Change Management
  • Training
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