Pharmaceutical product development
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Quality Assurance and compliance consulting in the pharmaceutical industry

  • 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 outlicensing 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.

Reliable outsourcing - contractor management

We retain complete independence and accept no fees from any contractors. Successful contractor management is about establishing good relationships with key people at all levels within the UK and Europe and about having the right information about your supply chain available to help you make your decisions. An essential part of supplier management is auditing. Our staff are trained to audit against GMP, GLP, ICHQ7, ISO 9000 etc. We will carry out one-off audits for you, for supplier selection or to address a specific need, or we will design and manage a full audit programme for you. In all cases your QP will receive a full report and be able to make decisions with confidence.

Supply chain optimisation

We will review your supply chain function using a top-down approach to ensure you’re obtaining all possible benefits from recent developments in lean manufacturing and supply - both for clinical trial materials and products. Our experts can assist you in identifying low cost, but reliable sources of API, products and packaging materials and put these together to help you maximise your return on product investment.