Six service lines. One standard of documentation.
Everything behind your inspections, submissions and product releases, from SOPs to pharmacovigilance.
Quality systems and GxP documentation
Documentation across every quality function, written to be 21 CFR Part 11 compliant and ready for an inspector to read.
Validation and qualification
Lifecycle documentation that proves your equipment, processes and systems do what they are meant to do.
Audit and inspection readiness
Preparation, support and response for regulatory inspections and customer audits.
Regulatory, R&D and pharmacovigilance
Scientific and regulatory documentation from development through to post-market safety.
Medical device quality and documentation
Design and quality records for device manufacturers working to ISO 13485.
PMO, training and professional development
Programme management for critical projects, and training that keeps your people compliant.
Pick the model that fits your gap.
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.
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.