Location: Warminster , PA 18974 +1 (215)-443-7000
WHAT CAN WE SOLVE FOR YOU?
  • Highly experienced team focused on Solid Oral Dosage Forms
  • Concept Development
  • Quality Testing
  • Handle Low-Occupational Exposure Limit products
  • Clinical Supplies
  • Commercial Supplies – Manufacturing/Packaging/Testing
WE HAVE THE FOUNDATION TO MAKE YOU A SUCCESS
 
Technical Expertise
  • Experienced technical team capable of efficiently supporting the development, testing and manufacturing of complex solid oral products
  • Products with poor solubility
  • Polymorphic challenges
  • Products with poor stability
  • Vast experience in development and tech transfer
  • Co-operative project design
  • Detailed project management
Quality Systems
  • Designed to meet the expectations of FDA and other regulatory agencies
  • Detailed Standard Operating Procedures
  • Upstanding documentation and document control systems
  • Detailed analytical methods and protocols
  • User-friendly Batch Manufacturing Records
  • Dependable warehousing and inventory management systems
  • Facility and equipment calibration and preventive maintenance program
  • “Safety First” approach
  • Compliance with EPA regulations
Manufacturing Facility
  • Designed to handle Solid Oral Dosage Forms
  • Monitored for ISO 8 standards
  • Designed to support efficient and quality workflow
  • Dedicated area for drugs with low Occupational Exposure Limits
  • Total space: 150,000 sq. ft. Currently occupied 75,000 sq. ft.
  • US-based development, manufacturing and testing in Warminster, PA (less than one hour from Philadelphia, PA)
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