BioPharm Process Associates logo biopharmaceutical manufacturing, process development and due diligence
consultants

outsourcing manufacturing partner

BioPharm Process Associates consulting services


Who We Are

WE ARE A COMPANY OF CONSULTANTS WITH EXTENSIVE KNOWLEDGE AND EXPERIENCE IN:

  • International manufacturing site selection and analysis
  • Technology transfer under cGMP to corporate partners and contract suppliers
  • Strategic pharmaceutical operations management consulting
  • Organizational excellence, team building and operational analysis for entrepreneurial manufacturing organizations
  • Development and scale-up of robust and compliant manufacturing processes
  • Definition of and set-up of cGMP-compliant systems for manufacturing control, quality assurance and process, equipment and utility validation
  • Design, construction and validation of pharmaceutical manufacturing facilities, including both production and materials management automation

WE HAVE PARTICULAR EXPERTISE WORKING ON:

  • Contract and corporate partner manufacturing management
  • Budget projection and financial control of internal and external manufacturing
  • Interim manufacturing and operations management
  • Pharmaceutical manufacturing facility design and start-up
  • cGMP manufacturing layouts, configurations and equipment
  • Outsourcing and technology transfer of cGMP-compliant production
  • Scale-up and compliant technology transfer of biopharmaceutical and pharmaceutical products
  • Recovery and purification of biotherapeutics and vaccines
  • Preparation of CMC sections for regulatory filings and the creation and implementation of cGMP compliance systems

WE SPECIALIZE IN THE DEVELOPMENT OF:

  • Cost-effective and reproducible manufacturing processes
  • Process validation strategies
  • Organizational and system requirements to support manufacturing and operations
  • Efficient compliance systems and cGMP audits
 
 
Strategic pharmaceutical operations management consulting