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About

Our company is composed of specialised pharmacists and medical doctors with vast work experience in EU GMP and GDP approved sites as well as numerous years of regulatory positions such as Responsible Person (RP) and Qualified Person Pharmacovigilance (QPPV) positions. Our clients include international pharmaceutical companies based inside and outside the EU (3rd Country) as well as local distributors that require regulatory and licensing support.

The firm was set up to provide high quality regulatory assistance to clients involved in manufacture and distribution of medicinal products and other manufacturing requiring a Quality Management System in place.

EU Market Accession

We offer our expertise and professional know-how to enable both EU and non-EU pharmaceutical companies to successfully access the EU market. Our team of experts will ensure that your company achieves full compliance with the stringent requirements laid down by European Law in order to facilitate EU Market Access.

Maltese Tax System

Malta operates a full imputation system of taxation whereby shareholders in receipt of dividends from a Maltese registered company may credit the 35% tax paid by the company against their own Maltese income tax liability or obtain a refund of tax where shareholder tax is less than the 35% tax paid by the company.

Persons who are resident and domiciled in Malta are subject to tax on their worldwide income at the transfers of shares are mainly exempt from transfer duties for international business.

Keywords

eu market accession, contract responsible person, qualified person provision, eu gmp, gdp, gacp audits & licensing, fmd decommissioning of 2d bar codes, medical devices, pharmacovigilance, laboratory testing, contract manufacturing, clinical trials, logisticts consultation, food supplements & cosmetics registration

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Business Info

8
2010
Not Available

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