Quality Assurance Services

For Pharmaceuticals and Medical Devices

We help identify and address issues before they escalate, while establishing robust quality management procedures that support efficient project delivery and ensure alignment with current regulatory requirements and industry guidelines

Quality Management Systems

We conduct gap analyses of your existing procedures and support the development of robust systems that ensure high-quality outputs across all development activities. We help you implement compliant Quality Management Systems aligned with GCP, GDP, ISO 13485, ISO 9001, EU MDR 2017/745, and UK MDR requirements, enabling you to establish comprehensive procedures in accordance with current regulations and standards. We also support the transition of legacy systems to new regulatory requirements through detailed gap assessments. In addition, we can provide experienced personnel to integrate into your day-to-day QMS oversight activities.

Auditing (Internal, Suppliers, Regulatory Bodies)

Our experienced and qualified auditors can support all your QMS auditing needs. We conduct audits in accordance with GCP, GDP, ISO 13485, ISO 9001, EU MDR 2017/745, and UK MDR requirements, and can also assist in preparing your organisation for inspections by regulatory authorities, notified bodies, or approved bodies.

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.

Standard Operating Procedures

We can review and revise your current documentation or prepare new SOPs from scratch.

Mock Inspections

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

Quality Control

We can conduct QC review of your clinical study and regulatory documents, including Protocols, Informed Consent documentation, Clinical Study Reports, etc.

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