Regulatory Affairs Services

Regulatory Affairs, Maltese Translations, Proof Reading, Product Information, Linguistic review, marketing authorisations, variations, renewals, withdrawal, regulatory intelligence, legislation scanning, medicines authority, inspections, capa, internal audits, training, local representative, change control,  mah, marketing authorisation holder, Gap analysis, support, SOP, labelling, artwork, mock up.
Providing support and solutions in Regulatory Affairs

With over 13 years of experience we offer our regulatory expertise to companies in the various regulatory procedures required to register medicinal products. With reference to the European Medicines Agency (EMA) Centralised Procedure we can translate to Maltese language the Product Information (Summary of Product Characteristics [SPC], Patient Information Leaflet [PIL] and labelling) and perform Linguistic reviews or Quality (QA) checks as required. We can also submit new license applications to the Medicines Authority utilising various procedures such as Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP) and National Procedures such as Article 126(a) and Parallel Importation License.

We also provide our support to maintain product registrations through answering Authority queries and through timely submission of the relevant notifications, variations (Type IA, Type IB and Type II), renewal procedures, line extensions and withdrawals of marketing authorisations.

We support companies with the challenges that were brought about by Brexit. 

The Falsified Medicines Directive brought about various legal obligations to Marketing Authorisation Holders (MAHs) including serialisation of packs that must include the 2D matrix barcode (that contains the unique identifier, serial number, batch number and expiry date) and anti-tampering device (ATD). We can support MAHs to ensure all requirements for safety features are met and that the relevant yearly on-boarding registration fees are paid to MaMVO timely to avoid risk of incurring penalties due to late applications.

Due to the current coronavirus pandemic, companies may face a situation where a number of staff will suddenly become unavailable to carry out critical tasks. We can provide our professional support remotely to ensure business continuity during these difficult times brought about by COVID-19.

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