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Sourcing Inquiry Logo Peak to Peak Pharma

Peak to Peak Pharma

Regions
North America
Countries
United States
Size
1-5
Specialty
Biopharmaceuticals
Service category
Consulting - strategy and development
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Key services

Services

Peak to Peak Pharma provides a wide spectrum of vital services to the biotech/pharma industry. Below are the main areas of expertise.

 

Project Management

  • Owner’s Representation
  • Capital Project Management
  • Transition Management
  • Change Management
  • Commercialization Management
  • Contractor Identification & Management
  • Due Diligence
  • Risk Mitigation

           

Sterility Assurance

  • Aseptic Processing
  • Bio-Contamination Control
  • Environmental Monitoring
  • Sterility Testing
  • Alternative Sterilization Methodology
  • Containment
  • Bioburden Control

 

CMC Manufacturing

  • Sterile Dosage Form Development
  • Operations Management
  • Technology Transfer
  • Facility Design & Commissioning
  • Laboratory Design & Commissioning
  • CMC Submission Support
  • Supply Chain Development & Management

           

Quality & Regulatory Compliance

  • Quality System Development & Implementation
  • GXP Quality Documentation Development
  • Contract Vendor Selection, Qualification, Quality Agreements
  • Regulatory Preparedness Training, Mock Audits
  • Remediation – Warning Letters, Consent Decree, Gap Analysis
  • GXP Quality Auditing – cGMP, GLP, GCP
  • Pharmacovigilance – RiskMAP &  REMS Program Development
  • Clinical Trial Services – clinical study regulations, SOPs and training, clinical supply release

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