Our Regulatory Affairs team have extensive regulatory expertise encompassing new chemical and biological entities, as well as medicinal products containing established active ingredients, generic compounds and therapies for orphan indications.
Pegah Kiani reflects on the possible impact of Swixit and Turkxit on regulators working with the EU MDR.
Pegah Kiani, Director of Quality Assurance and Medical Devices, highlights what you need to know.
Regulatory Development Strategy
We can provide strategic advice and advice around submissions. We can prepare a Regulatory Development Plan that outlines the key submission hurdles and outlines a proposed MAA Strategy.
Scientific Advice, PIPs & OMPDs
We have significant experience of assisting clients with Scientific Advice and Protocol Assistance. We can provide full support for Paediatric Investigation Plans and Orphan Medicinal Product Designation in the EU.
Clinical Trial Documentation
We can prepare and coordinate all the necessary regulatory documentation you may require for a clinical trial in the UK and EU, including IMPDs, IBs, CTA documents (including ensuring it meets local requirements), submit to the Competent Authorities and follow through to determination, as well as CTA maintenance.
Dossier Review & Gap Analysis
In support of client companies licensing during product development or post-approval, updating an older licence or converting from NDA to MAA, we can review and advise on additional requirements in line with current legislation and guidelines.
Quality Management System Development
We can help you implement a compliant quality management system in line with ISO 13485, MDR 2017/745, MDD 93/42/EEC or ISO 9001. We can help you establish comprehensive procedures, giving you confidence that your projects will run smoothly and be in accordance with the current regulations and guidelines. We can also help improve your existing quality management system.
Experienced and qualified lead auditors can train, educate and prepare personnel for audits or conduct audits (internal and independent self-inspection audits as well as supplier audits as part of routine supplier assessment or due-diligence qualification) in line with ISO 13485, MDR 2017/745, MDD 93/42/EEC or ISO 9001. We can also help you prepare for EU Notified Body and UK Approved Body audits
We can help to identify and resolve problems before they escalate and establish comprehensive quality management procedures, giving you confidence that your projects will run smoothly and be in full compliance with the current regulations and guidelines.
Quality Management Systems
We can conduct gap analysis of your current procedures and help you build a robust system that ensures high quality output from all your development activities.
Standard Operating Procedures
We can review and revise your current documentation or prepare new SOPs from scratch.
Promotional Material Review
There are strict rules and codes of practise to be adhered to for the advertising of medicinal products. Non-promotional information such as press releases can also be considered as disguised advertising. Therefore careful review and scrutiny of any outgoing pieces is critical. S-cubed has experience and can assist with the review of materials for both prescription and non-prescription products.
We can advise companies on the requirements of the GDPR for clinical trial activity in the EU. For further information please contact us.
MAAs and Licence Maintenance
We are assisting many organisations with their MAAs pre-approval and MAs following licence grant. Although the procedures to be followed are well-documented, they require careful management and experience of dealing with the Regulatory Agencies to navigate through the procedures effectively.
EU SME Status, EU OMPD Holder
We can support you and advise on whether you meet the SME criteria and assist you with all aspects of SME status in the EU. If you are a non-EU company, we can act on your behalf in the EU, if you meet the requirements. Similarly we can apply for, and hold Orphan Medicinal Product Designation on behalf of our non-EU clients.
Regulatory Intelligence Position Papers
Clients often have a regulatory or product development question which they need help to address. We can prepare Regulatory Intelligence Position papers to address these sorts of questions, summarise a topic of interest whether that relate to a specific indication for a medicinal product or product type, to produce a report to outline the regulatory issues for consideration and if needed, provide it in a presentation format for discussion within a client organisation.
Regulatory Technical Support
We can provide you with expertise in order to support your needs for CE marking purposes in line with MDR 2017/745 or UKCA marking in accordance with UK MDR 2002.
Quality and Technical Agreements
As part of quality management system requirements you may have the need for quality agreements to be drawn up with your suppliers. We have the expertise to help with quality agreements and establishing required elements in order to meet the current regulations.
Medical Device Lifecycle Management
We can provide you with advice to guide you through the requirements of medical device lifecycle management.
GxP System, Project and Vendor Audits
By assessing your processes and ongoing projects, we can give you assurance that quality is being maintained across the board.
Let us take the uncertainty out of agency inspections by conducting an on-site test run.
We can conduct QC review of your study and regulatory documents, including Protocols, Informed Consent documentation, Clinical Study Reports, etc.
EU Legal Representative
We can be your local EU representatives. The Authorized Representative is the door to Europe (EEA, Switzerland and Turkey) and a regulatory requirement.
As a requirement of the GDPR legislation in Europe, the large scale collection of health related data requires the appointment of a Data Protection Officer (DPO). S-cubed has experience of acting as a DPO. We can coordinate all necessary tasks related to this role and ensure general compliance with the GDPR
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