Regulatory


Regulatory Compliance


The quality of our products and standards of control are paramount to Macfarlan Smith. We provide our customers with the assurance that our products are manufactured to the highest levels of a cGMP (Good Manufacturing Practice) and supported by a full regulatory package.

Macfarlan Smith is regularly inspected by authorities such as FDA and MHRA. Compliance to cGMP for APl's and intermediates is carefully assessed during site visits by these authorities.

Product Registration


Macfarlan Smith provides full regulatory support dossiers for its products and works closely with customers to ensure successful registrations. Products are supported by:

  • DMF's
  • CTD's
  • Certificates of Suitability
  • lnformation to support IND /NDA /ANDA applications.