REGULATORY COMPLIANCE FOR PHARMACEUTICALS

We assist pharmaceutical companies to comply with relevant U.S. regulations for:


Pharmaceuticals - Veterinary & Human

  • R&D planning - Short & long term.
  • Planning & monitoring safety & tolerance studies.
  • Planning clinical trials.
  • Protocol development, report preparation, regulatory editorial reviews.
  • Drug product submissions (NADA/NDA, INAD/IND, VMF/DMF, DERs, MCSRs).
  • Manufacturing control audits to ensure regulatory compliance.
  • Facilty CGMP audits.
  • Responses to 483 reports & warning letters.
  • FDA liaison for product submissions & quality compliance.
  • Management procedures & training for regulatory inspections.
  • Validation master plans, processes & practices.
  • U.S. labeling requirements.
  • Process validations.
  • Aseptic & sterile processing to meet sterilization requirements.
  • Facility design.


For more information regarding this service and others, please contact us


IN THE U.S.:
Phone: 888-326-3311
Fax:     972-446-6622
E-mail: Webmaster


IN THE U.K.:
Phone: +44 (0) 1243 779550
Fax:     +44 (0) 1243 781563
E-mail: bpearce@shotcarr.com