Regulatory Affairs

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.

We know that regulatory advice is crucial to your product’s success.
As our client, we will ensure that you receive the best and most up to date advice.
Ask us how we can help.

Our Services | Regulatory Affairs

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 (QMS)

We can help you implement a compliant QMS in line with ISO 13485, EU MDR 2017/745, UK MDR 2002 (as amended) and ISO 9001, to help you establish comprehensive procedures in accordance with current regulations and standards. We can also carry out gap analysis of existing systems that require transitioning to new requirements. Additionally, we can provide personnel to integrate within the day to day QMS oversight activities.

Auditing (Internal, Suppliers, Regulatory Bodies)

Our experienced and qualified auditors can meet all your QMS auditing requirements. We can perform audits in line with ISO 13485, EU MDR 2017/745, UK MDR 2002 (as amended) and ISO 9001. We can also help you prepare for Notified Body or Approved Body QMS audits.

Quality Agreements

As part of supplier management requirements you may require quality agreements to be drawn up. We have the expertise to help with quality agreements and establishing elements to meet various requirements.

Quality Assurance

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.

GDPR Consulting

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 Affairs

We can provide you with a wide range of regulatory affairs support for EU and UK:

Device classification
Technical File development
Clinical investigations document preparations and submissions
Notified Body and Approved Body interactions
Drug/device combination product expertise
Regulatory strategies for approval
Expertise in CE or UKCA marking submissions

Post Market and Medical Device Lifecycle Management

We can provide you with advice to guide you through the requirements of medical device lifecycle management and post market activities. We can support you with activities such as ongoing post market surveillance, periodic safety reviews, device classification specific post market commitments and clinical evaluations.

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.

Mock Inspections

Let us take the uncertainty out of agency inspections by conducting an on-site test run.

Quality Control

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.

DPO Services

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