- 0Offices globally
- 0+Countries, serving clients globally
- ISO 9001:2015Certified quality management
End-to-end regulatory and quality services, delivered inside your systems.
Quality & Technical Operations
Quality operations, technical operations, quality and stability, and eLab support, run inside your systems to 21 CFR Part 11 and ISO standards.
- Quality Ops
- Technical Ops
- Quality and Stability
- eLab
Regulatory Affairs and Patient Safety
Regulatory filings, product lifecycle management and labelling, together with pharmacovigilance that protects patients.
- Regulatory Filings
- PLCM
- Labelling
- Pharmacovigilance
PMO & Trainings
Product and project management, with LMS support, instructor-led trainings and GxP trainings for your teams.
- Product & Project Management
- LMS
- ILTs
- GxP Trainings
Quality Management System (QMS)
Day-to-day QMS records handled end to end, from deviation to audit compliance.
- Deviation
- Change Controls
- CAPA
- Actions
- Audit & Compliance
ESO & Vendor Management
External supply operations and vendor oversight, backed by clear agreements and audits.
- External Supply Operations
- SLA
- QTA
- Vendor Audits
Where inspections are won or lost.
Every deviation should travel the same loop, and every step leaves a record. Click a stage to see what Pruvance writes for it.
Built for regulated industries.
Pharmaceutical
Quality operations, manufacturing documentation and regulatory submissions.
Medical Device
Quality records, regulatory affairs and post-market surveillance.
Biotech
Technical documentation, validation and regulatory strategy.
Consumer
Regulatory and quality support for consumer products.
Serving life sciences organizations globally.
Five offices across the USA, Canada and India, and clients in 18+ countries.
Scientific expertise with regulatory judgment.
With deep industry expertise and a commitment to innovation, we help clients navigate complex regulatory landscapes efficiently, ensuring product success and patient safety.
Compliance
Every deliverable is built to the regulation it must satisfy, then reviewed against it.
Data integrity
Records that are attributable, accurate and traceable, from first draft to final approval.
Scientific excellence
Writers who understand the science behind the document, so it survives expert scrutiny.
Security
Your confidential information is handled in a controlled way and used only for project execution.
Partnership
We work as an extension of your quality and regulatory teams, not as an outsider.
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.