Speak directly with our compliance specialists. Receive expert guidance tailored to your project.
As a leading pharma engineering and compliance solutions provider, IncepBio supports pharmaceutical and biotech companies in achieving regulatory readiness through IncepOne digital compliance solutions and the ValBio compliance partnership program.
From concept engineering to facility handover and ongoing compliance, one partner for regulated facilities.
Commissioning, qualification and validation aligned with global GMP standards.
ExploreParticle counting, HEPA filter integrity and recovery testing for classified cleanrooms.
ExploreAirflow visualisation studies for aseptic areas, RABS and isolators, with video records.
ExploreThermal mapping and precision calibration for pharma equipment.
ExplorePLC, SCADA and DCS systems for environmental and process control.
ExploreGAMP 5 risk-based computer system validation and data integrity.
ExploreCleanroom validation and contamination control for cell and gene therapy facilities.
ExploreConcept-to-commissioning cleanrooms, process HVAC, utilities and audit-ready handover.
ExploreTell us about your facility and our engineers will recommend the right scope.
Software and dedicated engineering teams that make validation easier to run and easier to audit.
SoftwareCloud-based platform for validation lifecycle management, protocol execution, activity tracking and audit trails.
Partner modelOn-site and remote engineers who support your validation, requalification and thermal mapping as an extension of your QA/CQV team.
Validation and engineering support for regulated and controlled environments.
Formulations, OSD and GMP equipment qualification
Bioprocess, clean utilities and biosafe suites
Smoke studies and Grade A/B isolator validation
CAR-T suites, cryo-storage and modular cleanrooms
Bulk active ingredient zones and reactor qualification
Controlled environments and packaging validation
Lab instruments, biosafety cabinets and stability chambers
Cleanroom particle and micro-vibration testing
Engineering design and field-tested validation methods, delivered as audit-ready outcomes.
Facility HVAC design, cleanroom setup, qualification and ongoing compliance from one team.
Protocols aligned with US FDA, EU GMP Annex 1, WHO GMP, PIC/S and GAMP 5.
URS, FRS, DQ, IQ, OQ, PQ and VMP documents prepared for audit review.
CQV engineers, thermal validation specialists and CSA/CSV consultants on your project.
21 CFR Part 11 compliant digital tools, audit trail reviews and real-time monitoring.
Requalification, calibration, routine smoke studies and preventive compliance support.
Certified quality and safety systems, with methods aligned to global regulatory guidelines.
Quality management
View certificate
Occupational health and safety
View certificate21 CFR Part 11 and cGMP
EudraLex Volume 4, Annex 1
Technical Report Series
Risk-based CSV framework
Cleanroom classification
Indian GMP requirements
Honoured for engineering excellence, cleanroom compliance and long-term customer partnerships.
Conferred by HRH Sultan Nazrin Shah
Conferred by Biocon leadership team
Biocon Group, 2026
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