REgulatory Affairs and Quality Assurance


Supporting clients and their projects worldwide

  • We support our clients projects in over 35 countries around the world.
  • We have successfully been inspected by regulatory inspections from the TGA, PMDA, MHRA, Health Canada, MPA, IMB, FDA, and more.
  • All of our facilities are in good standing with all regulatory authorities, including DEA, EPA, OSHA, etc.
  • The Quality / Regulatory staffing has increased by over 100% in the last 5 years.
  • Our Quality Management System and supporting analytical processes are almost 100% electronic, to allow for more immediate access to the data that is relevant to your needs.


Audit request form

Are you interested in completing an audit at one of our seven sites? Download and complete the Client Audit Request Form below. Once completed, please email to

  • Upon completion of the form, you will receive an email confirmation of an agreed upon date, and any pertinent pre-audit information. 
  • We request your completion of this form at least 30 days prior to your desired audit date(s).
  • Audits are limited to no more than 2 auditors and 2 days in length at a mutually agreed upon time.

Thank you for choosing Alcami for your business needs, and we look forward to seeing you.

Client Audit Request Form