Regulatory Maintenance

Regulatory Maintenance

Regulatory Maintenance and operations in every Pharmaceutical market

We have a network of local affiliates and agents, who can provide local submission support and case management in any Pharmaceutical market. We have worked closely with these experts over many years – they allow our clients to flexibly approach any market and confidently comply with regulations.


We recognise how important QC teams really are in enabling successful Pharmaceutical research and development, and defining a Pharmaceutical business’s success. But, in our experience these groups are often under-valued and in some cases, can be perceived as working against the drug development process.

We know how to help QA teams change that perception, remove internal tension, improve their performance and demonstrate their value by:

Supporting in-house QC teams

We help Quality and Compliance teams assess, define and improve their current processes. This includes developing RACI matrices, building SOP frameworks, writing SOPs and operating CAPA management activities on your behalf.

Our team of Quality and Compliance professionals has worked in the industry for many years. We’re backed up by a network of experienced consulting partners who can support us and clients with local requirements and regulations.

Building reliable quality and compliance controls

We guide clients through the process of creating risk-based approach to their Quality Management Systems: providing risk assessments and implementing KQIs to manage and improve upon quality and compliance controls over time. We also help you to remain audit-ready and provide direct support to audits activities.

For organisations that are going through mergers or acquisitions, or encountering new legislation, we also provide due diligence and integration support.

Our goal is to help our clients build a self-sustaining quality culture throughout their organisations.

Minimising risk

Organisations with strong Q&C processes are far less exposed to risk.

We work with our clients’  drug development and commercialisation functions to minimise compliance risks, while recognising that the pace of drug development must remain unimpeded.Paragraph

Developing drugs quickly, while remaining fully compliant? With the right support, your organisation can achieve this.