Regulatory Affairs

Strategy & Expert Process Support

The implementation of a comprehensive and integrated regulatory strategy is of utmost importance within an increasingly regulated, complex and changing environment. At Agos Pharma, our expert team can help. We can develop a regulatory roadmap of activities needed to successfully gain marketing approval in Europe and we can implement any or all of the development processes for you, from product development, PRIME, orphan designation, scientific advice/protocol assistance meetings (EMA/National Competent Authorities), paediatric planning, early phase clinical trials through to pivotal trials. We will assess the optimum regulatory route (centralised, decentralised and mutual recognition), define which target countries you should access first and advise on choice of reference member states (DCP/MRP).

Presence in the EEA and UK

Our Regulatory Affairs group can facilitate and enable activities that require a European and presence such as SME status and Orphan Sponsorship. We can also enable all UK regulatory activities.

Potential benefits for company’s assigned SME status by the EMA include administrative, regulatory and financial support. Fee exemptions and significant fee reductions are available for pre- and post­authorisation regulatory procedures, including scientific advice. Agos Pharma hold SME status for our European office based in Ireland which enables you to take advantage of our own SME status. Alternatively, we can assist you with your own SME application providing you meet the three main criteria relating to staff headcount, financial turnover and balance sheet and ownership structure.

To apply for Orphan Drug Designation, the sponsor must be established in the European Union. The Agos Pharma team have extensive experience in orphan submissions and can act as the EU sponsor on your behalf.

Document creation and submission

Agos Pharma have extensive experience in compiling dossiers for a range of regulatory submissions including: CTAs, PRIME, ODDs, Scientific Advice/Protocol Assistance, PIPs, RMPs and MAAs. We can project manage the entire process for you from the initial document draft, ongoing review, final client approval, prior to submission to EU and national regulatory authorities. We can also provide eCTD compilation and publishing, technical validation and submission to health authorities via eSubmission Gateways.

Post Authorisation Support

Agos Pharma provide regulatory support for all stages of product lifecycle management for your approved product. Updates to the product dossier may be required to maintain compliance with current guidelines and to implement changes to the manufacturing process.

Variations

We can help manage changes to your product dossier by providing an optimised variation submission strategy, including, authoring, eCTD publishing and submission of the appropriate variation.

Post authorisation studies

After product approval you may be required to complete certain activities which may include further clinical studies or updates to the manufacturing process. These activities can be categorised as Post Authorisation Measures (PAMs), Post Authorisation Efficacy Studies (PAES) and Post Authorisation Safety Studies (PASS). The Agos Pharma regulatory team will liaise with our Clinical Development group to design the optimum strategy for post authorisation clinical/efficacy studies. We can guide you through the entire process from designing the studies, liaising with regulatory agencies and submission of the final study reports.

Risk Management Plans

An update of the RMP may need to be submitted at any time during a product’s lifecycle. Agos Pharma can help with all procedural and regulatory aspects relating to life cycle maintenance of the RMP.

Periodic Safety Update Reports

A PSUR is an important pharmacovigilance document which provides an evaluation of the risk-benefit balance of a medicinal product at defined time points post-authorisation. We can help author, review and submit your PSUR and advise on strategy to harmonise PSUR cycles.

Agos Pharma can also provide assistance with other post approval activities such as, Renewals, Transfer of Ownership, Marketing and Cessation Notifications and Sunset Clause Monitoring.


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