Alliance Contract Pharma Quality

Quality Assurance

Alliance Contract Pharma, LLC understands that you hold your contract manufacturers and laboratories to the highest expectations for cGMP compliance. Our team has the knowledge, education, and training to ensure that your project will be completed and documented to the highest standards in the industry.

All of our processes are supported by US and EU compliant cGMP procedures in conjunction with a robust on-going training program. Our facility and equipment were designed, built and are fully qualified to meet and/or exceed all current regulations and guidance.

Licensing and Registrations:

  • Pennsylvania Dept. of Health Prescription and Non-Prescription Drug and Medical Device Manufacturer, Distributer and Wholesaler
  • U.S. Food and Drug Administration Drug Establishment FEI 3007884119/ Labeler code 75969
  • Analytical DEA License Number RA0396831 for Schedules I - V
  • Manufacturer DEA License Number RA0403078 for Schedules I - V
  • FDA Food Facility Registration Number 13781101748
  • All FDA Inspections have yielded approvable recommendations with no 483/observations
  • EU QP Inspected
 

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