Consultancy

QA questions

Are you a small start-up company, not knowing where to begin in setting up your quality system? Are you faced with an audit report and need help for quality improvement? Do you outsource the production and analysis of your first clinical batches? What kind of contracts do you need, which license is appropriate? PROXY provides assistance.
Are you a (non-)pharmaceutical company faced with a customer demanding a GLP, GDP or GMP-license? PROXY can evaluate your existing system, help you in upgrading to the required level and train your staff.
Do you want to import pharmaceutical products into the European Union? They need to be analysed within the EU and then be released by a Qualified Person (QP). PROXY offers both.

QA expertise
PROXY has many years of experience in operating within the (bio)farmaceutical industry. Analysis of raw materials (actives and excipients), utilities (water, gases), product intermediates and finished drug products is our core business for which we are GMP-certified. Analytical method development and validation is often performed on a low-cost basis, but may also be performed under GLP-accreditation. Stability studies require climate-controlled storage facilities, which must be continuously monitored to guarantee proper storage. These storage facilities enable PROXY to store and distribute small amounts of finished products, for which a GDP-license was granted. Additional regulations for certain chemicals, raw materials and finished products, require separate licences, such as for precursors and opiates.
These licences have been granted based on a well-defined quality system which complies with all relevant requirements, but which is also efficient to manage. On average, the quality system of PROXY is audited by government officials or clients every 2 weeks, and any remarks or observations are used to update the quality system

QA flexibility
In the life sciences industry quality rules the world. However, quality is not synonymous for expensive. An efficient quality system facilitates the competence of your company and prevents time consuming and costly mistakes. Our approach to enhancing quality is to train your personnel in maintaining a pragmatic quality system based on your requirements and regulations. Key documents are drafted in close collaboration with your personnel, while the basic system is defined, implemented and maintained by your own staff.

QA services
In summary, PROXY can assist you in:

  • Reviewing an existing quality system
  • Setting up or improving a quality system
  • Auditing facilities
  • Training of personnel
  • Import analysis of finished products
  • Qualified Person release

Should you have become interested in our approach to offering quality assistance and if you are looking for another kind of service in the area of quality assurance, then we are more than willing to explore the different ways in which we can be of help to you.