Regulatory and quality solutions, end to end.
From PMO and technical operations to regulatory affairs and pharmacovigilance, delivered securely inside your systems.
PMO (Project Management Office)
Governance, planning and delivery support that keeps critical projects on time and inspection-ready.
Technical Operations
Manufacturing and validation documentation prepared by specialists who understand the process.
Quality Operations
Day-to-day quality management, run inside your eQMS and ERP, to 21 CFR Part 11 and ISO standards.
Quality Control Documentation
Laboratory data, stability analytics and certificates handled with data integrity at the core.
Training Management
Training content, mapping and records that keep every team member qualified and every record audit-ready.
External Supply Operations (ESO)
End-to-end oversight of contract partners and the external supply chain, with vendor management built in.
Regulatory Affairs
Strategy, dossiers and health authority interaction across the product lifecycle.
Pharmacovigilance
Safety case handling and reporting that protects patients and satisfies regulators.
Quality consulting and contracting, your way.
Project-based
A defined scope, timeline and set of deliverables, such as a validation package, a document remediation or a 483 response.
Dedicated support
Specialists who work alongside your team to cover resource gaps and keep critical projects moving.
Ongoing quality support
Continuous help with SOPs, change control, CAPA and training records so you stay inspection-ready.
Straight answers.
How do you work with 21 CFR Part 11 and ISO standards?
Our teams work securely inside your systems (VDI, eQMS and LMS), following 21 CFR Part 11 and ISO standards, so records stay attributable, accurate and traceable.
Which sectors do you support?
Pruvance offers end-to-end services to Pharmaceutical, Medical Device, Biotech and Consumer sectors.
Can you cover a resource gap in our team?
Yes. We provide quality consulting and contracting support, either as a defined project or as ongoing support alongside your own team.
What services do you offer?
PMO, Technical Operations, Quality Operations, Quality Control Documentation, Training Management, External Supply Operations, eQMS, Regulatory Affairs, Pharmacovigilance and Vendor Management.
Where is Pruvance based?
We have offices in Gainesville, Florida (USA), Toronto, Ontario (Canada), and Mumbai, Pune and Nagpur in Maharashtra (India), serving clients in 18+ countries.