Our experts will guide your regulatory strategy to help you get the most from your products in the best possible timeframe, offering project management and support of your product development as well as registration. We can provide support in dossier preparation and registration, including co-ordination of scientific advice, product labelling preparation, along with continued support with lifecycle management including variations, renewal and transfer of marketing authorisations.
We assist with all your regulatory affairs requirements including:
Preparation of regulatory dossiers for the UK, Europe and other markets
Management of EU mutual recognition and decentralised licensing
Preparation of Quality Overall Summaries, Nonclinical and Clinical Overviews
Preparation or reformatting of DMFs into CTD format
Licence maintenance including variations, renewals and Change of Ownership applications
Advice on and preparation of SmPCs, labelling and leaflets
Liaison with Regulatory Authorities
Preparation of applications in e-CTD format’ and due diligence of dossiers
Our regulatory expertise can help optimise your development program and avoid unnecessary delays by:
advising on your development process, evaluate the risk-benefit profile, ensure the generation of the best data for your registration filing, and work with you to develop the optimal regulatory strategy to fit your requirements on timing, budget and markets of interest
helping you navigate through the relevant legislation, national guidelines and specific requirements to ensure regulatory compliance, providing regulatory advice for exploratory development programs and ensuring a smooth regulatory transition between the key phases of early development
helping you get the most from the scientific advice procedure with regulatory authorities
We have ample experience of all variation types, and can manage your procedure efficiently – whether it is an MRP/DCP, Centralised or a National procedure. We will guide you through the classification process and advise you on the most appropriate regulatory strategies.
We can also assist with post licensing activities, including:
regulatory compliance advice for any post licensing activity
reviewing and updating all documentation included in PBRERs, SmPCs and labelling
managing all regulatory authority communications for post licensing activities
provide strategic advice on regulatory requirements and submission routes for post licensing activities which can improve the financial outlook of your product
advising on appropriate variation filing strategy and ensure the appropriate supporting documentation are supplied
Other services include:
Risk management plans (RMPs)
Regulatory compliance projects
Change of ownership
Sunset clause management
Review of advertising and educational materials
QUALITY MANAGEMENT SERVICES
We provide a leading edge strategic consultancy in Quality Management and offer a full complement of services from first entry, to market approval.
Our experts have many years experience of working with organisations in assessing and meeting their quality needs and understand that these needs change as products progress and businesses grow.
Areas of expertise include:
EU/UK GMP compliance audits
Mock and Pre-Approval Inspections
European batch release, importation and re-testing
Development and implementation of phase-appropriate quality management systems
We offer analysis, development planning and targeted portfolio services, offering you objective advice, improving your decision making, with advice on a sound quality system that can enhance your organisation through an iterative process of continuous improvement.