KSi Malta provides its clients with tailor made regulatory strategies and solutions when it comes to the pharmaceutical industry. Our areas of expertise include, but are not limited to:

  • Regulatory Affairs Services
  • Medical Products & API Licensing
  • Wholesale Dealers License Attainment
  • VWL Attainment (Virtual Wholesale Dealer’s License)
  • Contract Laboratory Testing and Batch Release
  • Contract Manufacturing
  • Contract QP and RP Services
  • GMP/GDP Audit
  • Training and Education
  • EU Market accession
  • Local Representation

We understand that clients require fast turnaround times due to competitive pressures and fully appreciate that the first-to-market approach is of critical importance. That is why our team of highly specialised regulatory professionals is available round the clock, protecting our clients’ investments.

Malta is the ideal place to conduct your business thanks to its highly skilled English speaking professional workforce and booming pharmaceutical industry. Since its accession into the EU in 2004, Malta’s responsibilities as a member state include conformity assessments (Mutual Recognition) with other member states and non-EU countries. This is ideal for companies who set up in Malta and require recognition inside and out of the EU.

Malta also boasts a positive financial regulatory environment with one of the lowest effective tax rates in the EU. The local competent authority, the Malta Medicines Authority, is very consistent with its deadlines and timeframes and charges some of the most inexpensive fees in Europe.

KSi Malta, through its experts, is constantly in liaison with the Authority and frequently reserves slots to ensure timely outcomes for projects entrusted in our care.


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