Marketing authorisation applications
JSRS can support clients wishing to submit marketing authorisation applications within Europe (and/or worldwide). JSRS specialises in the Irish and Maltese markets in particular, but can also support clients wishing to register products across a range of markets. We provide support in regulatory strategy, dossier writing and other administrative aspects, depending on client requirements.
JSRS has extensive expertise in post-approval maintenance, and can provide a range of services from assuming complete regulatory oversight/responsibilities for your product portfolio (or part thereof), to providing ad hoc support for specific projects or unexpected/temporary peaks in workload.
JSRS can advise clients on a recommended regulatory strategy, based on their business objectives, resource constraints and the regulatory landscape. Investing in the right regulatory strategy from the offset will ensure that client objectives are met in the time- and cost-effective way.
Mergers, acquisitions & divestments
JSRS can support clients in all regulatory aspect of mergers, acquisitions and divestments (e.g. transfer of ownership applications, project management, labelling updates).
Dossier (CTD) preparation
JSRS can support clients by writing or updating dossier sections based on requirements (e.g. marketing authorisation applications, variations). We can also support clients wishing to transition from paper to electronic dossier formats, and can manage baseline module 3 submissions with the relevant competent authority as required.
Artwork (leaflet & labelling)
JSRS can manage all text updates to product information, and can review labelling/leaflet mock-ups to ensure that updates will be correctly reflected in the final packaging. We can also track and manage the artwork change process, based on client needs.
JSRS recognises that companies will often face temporary or unexpected peaks in workload (e.g. as a result of legislative or business changes). Outsourcing regulatory work to us reduces the risk for employers, and is a cost-effective alternative to recruiting permanent headcount. JSRS can also support clients when specialist input is required in meeting regulatory obligations or commercial objectives. We can manage everything from full regulatory oversight of a portfolio, to Brexit preparation, to preparation for serialisation, to supporting clients transitioning from paper to electronic dossiers. We can generate a bespoke package which is tailored to each client’s requirements.
JSRS can support companies who are preparing for the regulatory implications (and associated workload) of Brexit. We can review client portfolios and create an action plan, as well as supporting clients in its execution (e.g. RMS transfers, variations to update batch release sites, transfers of MAH).
JSRS can write and update abbreviated prescribing information (required for certain promotional materials) and can review promotional materials for compliance with the applicable legislation (e.g. S.I. No. 541/2007 Medicinal Products (Control of Advertising) Regulations 2007 in Ireland).
JSRS can work with medical device manufacturers/distributors to make sure they are ready for implementation of the new EU regulations. Please contact us to discuss your requirements.
JSRS can support clients in meeting their legislative obligations for the manufacture and/or supply of cosmetics in Europe. Please contact us to discuss your requirements.
JSRS can assist clients who hold or wish to apply for a wholesale distribution authorisation (WDA) in Ireland. We can support clients in making their application to the HPRA, or in establishing a quality management system that will meet the requirements for ‘good distribution practice’ (GDP) in Europe. We can also provide contract Responsible Person (RP) services for clients holding a WDA.
JSRS can support clients in meeting their legislative obligations for the manufacture and/or supply of food supplements in Europe. Please contact us to discuss your requirements.
JSRS can create bespoke training packages and programs for regulatory professionals, which can be delivered according to client preferences (from face-to-face training, to creation of an electronic training package which can be delivered (and re-used) by clients as needed).
JSRS can support you in establishing or making improvements to your quality system (with particular emphasis on marketing authorisation holder or wholesale distribution authorisation holder responsibilities).
JSRS can support you in establishing a quality system, which meets the obligations for marketing authorisation holders in Europe. In particular, we can support clients who are preparing for MAH compliance (‘regulatory’) inspections in Ireland. We can also provide advice on ensuring that best practice for regulatory compliance is achieved on an ongoing basis, by working with clients to create gap analyses and to formulate corrective actions (or continuous improvements) as required.
In addition to supporting clients to establish a quality management system appropriate for their requirements, JSRS can also design/write standard operating procedures (SOPs) which will ensure best practice for regulatory compliance is achieved on an ongoing basis. By creating SOPs that are clear, concise and appropriate for the activities and systems in use, we can ensure that errors are reduced or eliminated, and ensure that new employees can be trained effectively.