Regulatory Affairs for Pharmaceuticals

Our team have comprehensive regulatory expertise to support the complete medicinal product lifecycle, from strategic early drug development to marketed products

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 you

Regulatory Development Strategy

We can provide strategic advice for your regulatory pathway. We can prepare Regulatory Development Plans that outline the key submission hurdles and provide proposed MAA Strategies, including supporting access to accelerated pathways such as PRIME and ILAP.

Scientific Advice, PIPs & Orphan Designation

We have significant experience in the management of Agency procedures including Scientific Advice and Protocol Assistance.

We can provide full support for Paediatric Investigation Plans and Orphan Medicinal Product Designations in the EU.

Clinical Trial Application

We can prepare, submit and maintain your clinical trial application through to end of trial in the EU and UK and have experience of the EU CTIS and the UK combined review procedures.

We can author Investigator Brochure’s, Module 3 IND and IMPDs, and ensure they meet current regulatory requirements.

Dossier Review & Gap Analysis

We can perform a dossier review and gap analysis from product development to post-approval and advise on additional requirements in line with current legislation and guidelines. We can convert from NDA to MAA to enable further regulatory submissions.

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.

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 have significant experience of managing national and centralised MAAs from submission to approval, including Regulatory Agency interaction throughout the EU and UK and those involved in International Recognition Procedures.

We can maintain MAs following licence grant, including all major and minor variations, line extensions, repeat use procedures and reclassifications.

Although the procedures to be followed are well-documented, they require careful management and interaction with the Regulatory Agencies. We have the expertise to navigate the procedures effectively.

Regulatory Dossier

We can author full Module 2 and Module 3 regulatory documents to support initial MAAs and variations.

Regulatory Publishing

We have in-house publishing capability for submissions to Regulatory Agencies to enable a complete end-to-end service from document authoring to submission.

Regulatory Intelligence

We can prepare reports on the latest changes in multiple areas of drug regulation, enabling you to keep up-to-date with any regulatory changes and meet your business needs.

We can prepare Regulatory Intelligence Position papers to address regulatory or product development questions, or summarise a topic of interest which outlines the regulatory issues for consideration.

We can provide presentations on a wide variety of regulatory subjects to enable knowledge sharing within your 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.

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