Market Authorisation Holding
A Marketing Authorisation is the essential authorisation that allows a medicinal product to be legally placed on the market. Our team supports companies in preparing and maintaining the comprehensive dossiers required for submission to regulatory authorities. This includes full eCTD submissions, covering administrative information, quality data, nonclinical and clinical reports, and all necessary regulatory documentation.
We advise on the most suitable regulatory route—centralised, mutual recognition, national, or decentralised—depending on the product type, target market, and company needs. We also provide guidance on portfolio management, ensuring that all products under a company’s MAH are compliant and strategically positioned.
Converting older dossiers into eCTD format is another critical service, ensuring that existing products remain compatible with modern electronic submission requirements. We also provide support for variations, renewals, and lifecycle management, safeguarding the value of your Marketing Authorisations.
Our approach is collaborative, working closely with clients to ensure applications are accurate, complete, and submitted in line with regulatory expectations. We liaise with competent authorities when necessary, providing expert guidance to reduce delays and improve approval outcomes.
By outsourcing MAH support to our team, companies gain access to regulatory expertise, practical advice, and a structured approach to managing their licences and market presence.
Ready to bring your products to market with confidence? Get in touch today.
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