Regulatory

At Smartway our philosophy is simple. We place our customer’s satisfaction and ultimately the patient’s wellbeing at the forefront. In Smartway you will have a partner who fully understands the complexities of Clinical trial supplies and complies with all the regulations, easing your logistical and regulatory burden.

Smartway holds a Wholesale Distribution Authorisation (Human & Veterinary) issued by the MHRA, Controlled Drug Licence (Schedules 2-5) issued by the Home Office and an MS licence which allows importation of products from outside the EU.

At Smartway CTS we can offer:

  • A fully licenced operation regulated and registered with MHRA
  • A dedicated and experienced Clinical Trial Supply team consisting of qualified doctors,dentists and pharmacists
  • A Responsible Person (RP) and trained supporting staff overseeing operations
  • Assurance that all procedures relating to logistics, warehouse and office duties are carried out in accordance with our SOPs, which are regularly reviewed and updated
  • Recall monitoring and batch traceability to protect the integrity of the clinical trial and patient safety as approved by MHRA
  • Associated documentation such as Certificate of Analysis (COA), Certificate of Conformance (COC) and TSE/BSE statements where applicable