Services include:
- Review of your manufacturing processes and submitted data
- Review of manufacturing facilities and quality management systems
- Audits of contractor facilities for supplier selection or GMP compliance
- Work with in-house QA experts to improve presentation of facility and systems for Inspector
- Prepare response documents or appeals on your behalf
- Identification of suppliers for API, drug product, distribution and marketing
- Supply chain optimisation for worldwide distribution of CTM and products
- Lean manufacturing and six sigma optimisation and implementation of manufacturing and supply
- Qualified Person services
The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient (ICHQ9)
Our experts have over 20 years experience in the multinational arena. We’ll help you set up the right quality systems covering the entire product lifecycle. This includes everything from product development and manufacture through to packaging, labelling and distribution.
We can also help companies import products into Europe.
We’ll explain what regulators require and ensure you have acceptable systems in place for both commercial supply and for clinical trials. QPs can be provided to release products for sale or for clinical use.
Preventing expensive delays
Quality standards are more than just satisfying regulators, they add real value to your business and can prevent expensive delays and reduce adverse inspection findings. For a small company developing medicines, having a robust quality management system assures the reliability of the data that you and your contractors produce, that you rely on for your day-to-day operations, and that you will rely on in any out-licensing or due diligence negotiations.
We take the fear out of the regulatory inspection process and ensure your procedures meet current standards.
It’s important you keep your systems current as standards are frequently updated by regulatory authorities. Quality systems should be seen as an investment for improving business and not just an expense.
Working on your behalf, we’ll work with you to achieve the best outcome to any regulatory inspection.
What we do:
- We’ll examine your manufacturing processes and submitted data
- We’ll carry out GMP reviews of manufacturing facilities and quality management systems
- We’ll audit your suppliers and contractors for compliance with GMP, GLP or other standards
- We’ll work with your QPs and other in-house QA experts to improve presentation of facility and systems for Inspectors
- We’ll prepare response documents or appeals on your behalf
- We’ll provide expert staff to serve as QP on your manufacturing licence
Quality management designed for your business
Every business is different and requires quality systems that work best for them. We’ll assess your needs and create a quality management system that suits your operation. We will assist you in meeting compliance with GMP, ISO 9000 and other best-practice quality systems.