Welcome

Cornerstone Pharma Consulting, LLC provides consulting services to the pharmaceutical industry based on broad large Pharma and virtual Pharma experience. Our expertise covers a wide range of dosage forms from oral solids to thin films and includes formulation development, process development, clinical trial material manufacturing, scale-up and optimization, and technology transfer. We can provide a solid foundation of technical excellence and pragmatic expertise for your drug development program. Our services include:

• Strategic review and guidance of development and regulatory plans
• Vendor sourcing and management of vendor services
• Review, provide recommendations or management of:
  • Formulation development
  • Process development and optimization
  • Clinical trial materials  -  manufacturing/packaging/comparators
  • Process scale-up and technology transfer
  • Author or Review key development documents such as Manufacturing Batch Records, Packaging Batch Records, Product Specifications, Stability Protocols, Clinical Supply labels, Product Development Proposals, Product Development Reports, Technology Transfer Plans, Investigational Reports, and Quality Audits
• Troubleshooting formulation and manufacturing problems
• Addressing cGMP Compliance and Quality Issues
• Review and technical writing of GMP documentation / SOPs
• Author and review regulatory documents
• Supply chain management and product lifecycle planning