Signifix B.V. is a consulting company with driven and experienced consultants in the field of medical devices (CE Marking), vaccines and other biologic medicines.
We offer quality and regulatory support, such as:
– Regulatory strategy
– Product files
– Interaction with authorities (Scientific Advice, EMA question and answer sessions),
– GMP Inspections, etc.
– Transferring R&D to production under GMP
– Quality Systems, Batch records, SOPs
We are happy to contribute to the fight against the COVID-19 and are available with immediate effect. Let us know!