Regulatory Compliance

PMRS has established and maintained a good working relationship with numerous regulatory authorities.

Current Licensing and Registration:

  • FDA Facility Establishment Number: 3004752030
    • No 483 Observations from last three FDA inspections (2006-2009)
  • PMRS complies with EU GMP according to 2003/94/EC
    • Positive results from MPA inspection (2006) and MHRA inspection (2009)
  • ISO 9001 Registration: effective February 28, 1998
  • ISO 14001 Registration: Effective September 25, 2002
  • ISO 27001 Registration: Effective October 2009
  • PA Wholesale Prescription Drug Distributor Lic. No.: 8000001596
  • PA Drug Mfg. Registration No.: 1000003011
  • DEA Controlled Substances Registrations:
    • Manufacturing: RP0218099 (II,IV,V)
    • Analytical: RP0334639 (I-V)

The PMRS EHS Committee is certified by the PA Department of Labor & Industry: Employer FEIN # 23-2779396

Testimonial:

"PMRS is ISO 9001 registered and has an outstanding track record with regulatory agencies in both the United States and the European Union including an MHRA Certificate of GMP Compliance. Client audits occur regularly and contribute to the PMRS continuous improvement program by strengthening the PMRS Quality System with best practices from throughout the pharmaceutical industry."
- Chad J. Beaver, Director, Quality Management
  • Pharmaceutical Manufacturing Research Services, Inc.
  • 202 Precision Road,
  • Horsham,
  • PA
  • 19044
  • p: 267.960.3300 |
  • f: 267.430.7677