Our Flexible Approach

We can be part of your team

We can function as an extension of your quality and regulatory team, offering flexible and scalable support to help you achieve your goals. From quality to regulatory compliance tasks, including conformity assessments, we help ensure that you receive the assistance you need whenever you need it. We can simplify your compliance processes, helping ensure that you deliver safe and effective products that meet all the necessary standards.

Even if you need support for a number of hours each month, we are here to help you.

You will have access to the necessary expertise to address your queries, manage a particular project, review, or conduct tasks based on your needs.

Projects

Engage with us on a project basis. Whether you require support for specific, routine tasks that your team may not have the capacity or expertise for, we can help you with:

• QMS                                            
• Internal audits                                                  
• Standard operating procedures
• Regulatory strategy
• Regulatory road map                                        
• Validation and verification
• Gap analysis                            
• Risk management                                
• Quality technical agreements
• Technical file compilation, review, maintenance, remediation
• Distribution agreements

Interim Support

We provide immediate interim support during times of resource issues, and our commitment provides you with an effective solution. Not having the expertise that you need leads to challenges in growth, knowledge retention, and project timelines. Our interim support will add value to any organisation in the long term, as we bring in and share the expertise you need.

We have supported many medical device and in vitro diagnostic companies, assisting them in filling skill gaps, rescuing projects, and implementing innovative ideas and processes. Our approach helps ensure quality results every time.

We have a proven track record and are dedicated to addressing your needs effectively.

QMS Management, Auditing and Maintenance

If you find it challenging to keep up with your audit programme, we can assist by managing your annual programme for you.

We will help you stay on track, identify areas for improvement, and address any issues within your Quality Management System before your Notified Body flags them.

We can serve as your QA/RA function temporarily, regularly, or long-term. We are committed to helping you remain compliant, ensuring that you deliver safe and effective products.