Licensing Support In order to engage in any pharmaceutical activity, one must have the proper licensing in place. Pharmaconsulta has been engaged time and time again to acquire licences on behalf of its clients ensuring a smooth and seamless transition when doing business in Malta.
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Laboratory Testing Our contract laboratories are all GMP audited and incorporate the latest state of the art technology as well as the highest standards of GMP and GLP. As a European Union member state, we can offer contract laboratory testing in order to certify products for accession into the EU market as well as batch release.
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GMP/ GDP Audit Auditing is a crucial part of GMP that ensures adherence to GMP requirements and is essential for continued licencing and operations. We provide employee training for GMP/GDP Audit reviews as well as on site GMP/GDP Audits and GAP analysis.
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EU GMP/GDP Compliance Good Manufacturing Practices is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
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Dossier Submission Review Manufacturers willing to place their products onto the european market may wish to do so via the centralised procedure.We offer regulatory and procedural guidance every step of the way.
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Contract Manufacture We provide contract manufacturing services through our affiliated GMP approved manufacturing sites. We offer both primary and secondary contract packaging as well as QC laboratory testing. All our sites are audited and equipped with the latest state-of-the-art-technology. We also provide re labelling of medicinal products as well as package re design.
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EU Market Accession We have the expertise and know how to enable EU and non-EU pharmaceutical companies to successfully access the EU market by advising on how to comply with the stringent requirements laid down by European Law.
Trade in the EU
Standard Operating Procedures Creation The development and use of Standard Operating Procedures (SOPs) are an integral part of a successful quality system, which is a pre requisite for Good Distribution Practice compliance.
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Contract QP/ RP Services Our team of Qualified (QP) and Responsible Persons (RP) operate in line with strict EU cGMP/GDP guidelines, releasing medicinal products for sale on to the EU markets after having ensured that such products are manufactured and imported by MA GMP licensed companies.
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Obtain a vWL licence A Wholesale dealer's Licence is required for the sale and distribution of medicinal products within the EU. Each and every pharmaceutical wholesale dealer requires a licence issued from the relevant regulatory body in that European country.
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Setting up a Pharma Company? A WL is required for the sale and distribution of medicinal products within the EU. Each and every pharmaceutical wholesale dealer requires a license issued from the relevant regulatory body in that European country.
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