What could possibly go wrong?

During drug development there are not surprisingly a vast number of things that can go wrong. The planning, manufacturing, testing, data integrity and subject protection, to name few. To avert and error-proof the development and manufacturing process what you need is to come up  with ways of operating that will ensure compliance, codifying these in your Quality Management System (QMS).

For the biopharmaceutical industry, product quality and regulatory compliance are fundamentals of business operations. Throughout drug development and all the way out into the market, your product is accompanied by quality standards and the requirement to meet them. Partnering with NDA will provide you with a thorough understanding of how your QMS must be developed for you to take ownership and build in quality from the start of each project.

If something is wrong, it’s better to find it yourself

Done right, execution of your strategies generates the right data, with the right end in mind. It is however not enough with an impeccable strategy – the clinical practices applied through trials and the management of the data collected are equally important to ensure your data can be put to good use. The same applies to your manufacturing activities. Even the smallest changes to your manufacturing environment can sometimes lead to significant changes to your product’s profile, particularly if it’s based on living cells.

In both of these cases you will be tested; the regulators will inspect you. And should you fail these tests it will cost you – in remedial action, investor confidence, but most of all in lost time. At NDA we work with you through development, helping you audit your providers, your CROs, and maybe most importantly, your own practices. This helps you strengthen them and understand how you are performing, preparing you to face any question the regulator can pass your way.

Getting ready to be inspected? That’s when we make sure every relevant aspect of your operation is pressure tested to get you over that hurdle with flying colours. Talk to us about inspection readiness – because when the heat is on, a field test will most likely cool the head.

Quality is not an act, it’s a habit

Or in other words, there is no such thing as a human error – it’s always down to the process. And the processes you operate should all be part of your integrated QMS.

The NDA Quality team are experts at process – observing it, describing it and implementing it. Using straight forward language and a streamlined approach to documentation, our quality documentation is comprehensive but concise and easy to understand. We work with your team to help train them and implement new or updated practices, because quality practices need to be integrated into your organisation’s DNA.

You cannot afford to base your product quality and regulatory compliance on a vulnerable system. This includes assuring the appropriate operation of the third-parties you rely on.

If you do not already have a system for implementing corrective and preventive actions, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, trends from process performance and product quality monitoring, let us help.

And when expertise is not enough, we provide leadership

Throughout the regulated domains, leaders must be well aware of key requirements and how these translate into operational practice. This is necessary to provide the leadership required to guide teams to do the right things in an efficient manner.

Our senior quality experts offer more than the expertise they’ve earned from years of experience – they can step in as interim leaders in your organisation. They can lead projects, teams or even your quality function for a period of time.

Going through a significant change project? Want to implement a new manufacturing process? Struggling with compliance with your QMS? 

An interim Quality Leader from NDA provides a focal point for all such activities and can help you build from scratch or develop what is already a good practice into a competitive, lean and highly productive way of operating.

 

 

 

Our services include
  • Interim Quality Leadership
  • Preparation for regulatory inspection
  • Quality Management System (QMS) Gap analysis
  • Development of a QMS roadmap including prioritization
  • QMS structure and documentation development (e.g. SOP Policy)
  • On-site quality management of projects
  • QA Validation support
  • GMP Auditing (e.g. Supplier Audits)
  • Quality Management Review

Our Services

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Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

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