- 0+Offices across India and Canada
- 0Countries, serving clients globally
- 0Specialist service lines
- ISO 9001:2015Certified quality management
Everything an inspector reads, written by people who understand the science.
Quality and compliance
SOPs, batch records, deviations, CAPA, validation and mock audits, built to 21 CFR Part 11 expectations and ready for inspection.
- SOP management
- IQ/OQ/PQ
- CSV
- Mock audits
- FDA 483 response
Regulatory and safety
Scientific and regulatory documentation from development to post-market, including CTD-related support and pharmacovigilance.
- CTD support
- Research protocols
- Technical reports
- Pharmacovigilance
Medical devices
Design controls and device records for manufacturers working to ISO 13485.
- Design History File
- Device Master Record
- Device History Record
- Risk management
Programmes and people
PMO support for critical projects and customised GxP, GMP and data integrity training for your teams.
- PMO
- GxP and GMP training
- Data integrity training
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.
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Higher inspection risk
Built for regulated science.
Pharma
Batch records, qualification and quality system documentation.
Biotech
Research protocols, technical reports and technology transfer.
CDMO
Audit-ready records for every client programme you run.
Life sciences and devices
DHF, DMR, DHR and ISO 13485 support.
Serving life sciences organizations globally.
Four offices across India and Canada, so your documentation never waits on a time zone.
Scientific expertise with regulatory judgment.
We combine scientific expertise, regulatory understanding and practical industry experience to strengthen quality systems, fill resource gaps and move critical projects forward efficiently.
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.
What does 21 CFR Part 11 compliant documentation mean?
21 CFR Part 11 is the US FDA regulation that sets out when electronic records and electronic signatures can be trusted as equivalent to paper. We prepare quality documentation and records so they are attributable, accurate, complete and traceable, in line with those expectations.
How fast can you help with an FDA Form 483 response?
Responses are generally expected within 15 business days of the observations, so speed matters. Contact us as soon as you receive them and we will scope the CAPA, remediation documentation and response support with you.
Do you work with small biotech companies and CDMOs?
Yes. Pruvance supports pharma, biotech, life sciences and CDMO organizations, from a single document set to ongoing quality system support.
Can you cover a resource gap in our quality team?
Yes. We help organizations address resource gaps and advance critical projects, either as a defined project or as ongoing support alongside your own team.
Where is Pruvance based?
We have offices in Mumbai, Pune and Nagpur in India, and in Toronto, Canada, and serve life sciences organizations globally.