Services

Pharmaceutical

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.

Schemes to aid pharmaceutical companies in Malta

Investment Aid Tax Credits 2014-2020

This incentive is aimed for projects where the ‘start of works’ is on or after 01/01/2018 and before 31/12/2020.

The total amount of investment aid (in the form of a tax credit) that may be awarded in terms of these regulations for a given investment project shall not exceed:

  • 30% of the qualifying expenditure for an undertaking which qualifies as a ‘Small’ undertaking
  • 20% of the qualifying expenditure for an undertaking which qualifies as a ‘Medium-sized’
  • 10% of the qualifying expenditure for an undertaking which qualifies as a ‘Large’ undertaking

Business Development and Continuity Scheme

Tax credits or cash grants of up to €200,000 over a period of 3 fiscal years may be awarded to undertakings that carry out a project aimed to expand their business operation and establish an operational base in Malta or to consolidate their current operations.

The value disbursed in any fiscal year shall not exceed the wage costs incurred by the single undertaking in that fiscal year.

Eligible Costs are:

  • Relocation of Key Personnel
  • Temporary Secondment of Personnel
  • Relocation Cost of Assets
  • Operating Expenditure
  • Wages and Salaries

Other schemes

  • Start-Up Finance: financing innovative undertakings in their early stages of development
  • Micro Guarantee: facilitating access to debt finance for smaller business undertakings

Business START: assisting small start-ups at the early stage of their development

 

Case Studies

 

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