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Quality assurance, quality control and regulatory affairs

Producing pharmaceutical and biotechnological products is increasingly challenging as a result of stringent regulatory requirements and technological developments.

Our consultants have extensive experience with quality assurance, quality control, compliance, internal and external audits and regulatory affairs:

Quality Assurance (QA)

Our quality assurance consultants can help you with validations and with setting up and maintaining compliance with your quality systems (change control and deviation handling).

Our senior registered auditors can help you prepare for audits in the most efficient way, with or without the help of mock inspections. We can also conduct official audits.

Quality Control (QC)

The qualification and validation of computerized systems, lab equipment, analytical methods and utilities is often seen as a burden. Rest assured though, our experienced consultants look forward to doing the job for you.

Regulatory Affairs (RA)

Pauwels Consulting can help you with on-site advice and assistance in relation to your regulatory requirements. We can assist you from the early pre-registration phase through to marketing authorization applications.

Our services include but are not limited to the development of regulatory strategies for product life cycles, dossier preparation and submission, review and filing, the preparation, review and submission of marketing authorization applications and facilitating interaction with the authorities.


Interested?

Are you interested in our services or do you have additional questions? Please call us at +32 9 324 70 80 or fill out the form below. We look forward to speaking with you.