(919)622-6396

Premier Quality Consulting, LLC

Providing Aids for the Pharmaceutical, BioTech, Medical Device, and Cosmetics industries.

Services

Quality & Compliance

  • Quality Assurance Validation
  • Quality Assurance
  • QA Reviews
  • Quality Systems
  • Quality Management Systems
  • Compliance
  • Deviations
  • CAPAs
  • Product Life Cycle
  • SOP Development

Validation & Commissioning

  • Bio-Tech and Pharmaceutical Process Validations
  • Validation Project Management
  • Validation Mentor-ships
  • Validation Master Plans
  • Transdermal Process Validation
  • Cleaning Validation (Manual/COP)
  • Equipment Qualification
  • Commissioning
  • FATs/SATs
  • ASTM E-2500 Implementation

Manufacturing & Technical Operations

  • Process Engineering
  • Manufacturing Support
  • Sterile Drugs (including Vaccines) Support
  • Oral Dosages
  • Process Scale-ups
  • Process Development
  • Process Optimization
  • Sterilizations
  • Chamber Mappings
  • Master Inventory Lists

Regulatory & Risk Management

  • FDA/International Regulatory Guidance
  • EU Assessments
  • Risk Assessments
  • Design of Experiments
  • Periodic Reviews
  • Investigations
  • Technology Transfers

Documentation & Systems

  • Batch Record Reviews
  • Document Reviews and Verifications
  • Technical Writing
  • Proposal Generation/Review/Issuance
  • Creating/Managing Supplier Quality Agreements
  • Vendor Management and Qualification
  • SharePoint
  • TrackWise
  • Veeva Vault

Leadership & Project Management

  • Project Management (PMP Trained)
  • Technical Leadership
  • Cross-functional Teams
  • Negotiations
  • Communications
  • Pharma and Bio-tech CMOs