Compliance
The implementation of a structure ensuring the compliance of an adapted quality system is a key element of the success of life sciences companies.
Validapro Biosciences “Quality and Compliance” department has extensive experience in the evaluation and implementation of organizational structures and quality systems meeting regulatory requirements. A number of our services are shown below:
- Analysis of FDA, HPFB, NHPD and EMEA regulatory requirements
- Audits / assessments of structures and systems in place, based on applicable regulatory references
- Supplier audits
- Audit reports detailing each non-conformance, their criticality, and the possible means for implementation of corrective actions
- Action plans / Quality Master Plans for compliance including assessment of needed resources and proposed implementation schedules
- Management of compliance programs
- Implementation of Quality Systems
- Writing of procedures (SOPs)
- Training
- Preparation for / assistance with audits from regulatory agencies
Validapro Biosciences also offers regulatory compliance services including:
- Liaison with regulatory agencies (FDA, HPFB, NHPD and EMEA)
- Preparation and filing of establishment licenses and applications (DIN, NPN, DIN-HM, DMF, PMA, 510(k))
- Assistance with replies to regulatory agencies (e.g. Warning letters, 483, etc.)
- Assistance with complaints, incidents and recalls