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COMMISSIONING · QUALIFICATION · VALIDATION

Validation,
engineered for
biopharma.

PMBS delivers next-generation commissioning, qualification and validation services for greenfield and brownfield biopharmaceutical manufacturing facilities — operating at the intersection of pharmaceutical engineering and validation science.

Request a C&Q proposal ↗ View capabilities
COMPLIANCE · REFERENCED FRAMEWORKS
US FDA 21 CFR Part 11 EU GMP Annex 11 Annex 15 ICH Q7 / Q9 / Q10 ISPE GAMP 5 PIC/S PI 041 WHO TRS EMA · MHRA · CDSCO
↳ SCROLL FOR SERVICES © PMBS PVT LTD
02
CAPABILITIES

Six capabilities.
One accountable partner.

PMBS brings C&Q, CSV, engineering and automation under a single delivery model — built for biopharmaceutical manufacturers operating to FDA, EMA and ICH expectations.

INDEX OF CAPABILITIES · 006
S/01 →
＋

C&Q

Commissioning & Qualification. Commissioning & Qualification plans, IQ/OQ/PQ, traceability matrices, V-model execution.
S/02 →
＋

CSV

Computer System Validation per GAMP 5 & EU Annex 11, 21 CFR Part 11. Risk-based and data-integrity first.
S/03 →
＋

Engineering

URS, P&IDs, mass balance, scale-up and tech-transfer for USP, DSP and Fill/Finish unit operations.
S/04 →
＋

Process Automation

DCS · PLC · SCADA · MES. Control philosophy, FAT/SAT and integrated commissioning.
S/05 →
＋

Design Engineering

Conceptual & basic design for greenfield and brownfield biopharma facilities, with HVAC and utility integration.
S/06 →
＋

Audit Readiness

GMP gap assessments, remediation plans and mock inspections for FDA, EMA, MHRA, CDSCO and PIC/S.
↳ ALSO : TECH TRANSFER · PROJECT MANAGEMENT · GMP TRAINING
END OF INDEX
We write to the framework your product is inspected against
FDA 21 CFR Part 11
FDA cGMP 210 / 211
EU GMP Annex 11
EU GMP Annex 15
ICH Q7 · GMP for APIs
ICH Q9 · Risk Mgmt
ICH Q10 · Quality Sys
ISPE GAMP 5
ASTM E2500
WHO TRS Series
PIC/S PI 041
CDSCO Schedule M
MHRA Orange Guide
03
SECTORS SERVED

Built for the
modalities of tomorrow.

From clinical-scale viral vector suites to commercial mAb facilities — PMBS supports a deliberate set of modalities where validation rigor is the difference between approval and delay.

M/01 →
◎

Biologics & mAbs

CHO, microbial, recombinant proteins, monoclonal antibodies.

M/02 →
◎

Vaccines

Viral vector, mRNA and conjugate vaccine facilities.

M/03 →
◎

Cell & Gene Therapy

Autologous and allogeneic platforms, viral vector production.

M/04 →
◎

Biosimilars

Comparability-driven C&Q for biosimilar manufacturing.

M/05 →
◎

Sterile Fill / Finish

Isolators, RABS, lyophilizers and visual inspection lines.

M/06 →
◎

API & Small Molecule

Solid dosage, OSD, parenterals and clinical manufacturing.

↳ BEYOND THE LIST

Not on the list? Talk to us. PMBS regularly supports utility, packaging and QC lab qualification programs.

Start a conversation →
04
THE PRACTICE

We commission the facilities that make tomorrow's medicines — and we hold them to the standards regulators apply today.

Pristinemed Bioprocess Solutions is a specialist engineering and validation partner for biopharmaceutical manufacturers. We bring deep expertise in C&Q, CSV, GMP compliance, DCS automation, design engineering and engineering to greenfield and brownfield facilities.

Our practice is founder-led and engineer-staffed — we put the lead names you signed onto the project floor, not just on the proposal. Every engagement is scoped against the regulatory framework your product will face, from IND through commercial launch.

05
§ 05 · ENGAGEMENT MODEL

Five phases.
One audit-ready outcome.

Whether we're embedded for the duration or scoped to a specific package, every PMBS engagement runs through the same phased model — designed for traceability under FDA, EMA and MHRA scrutiny.

PHASE · 01
Discover
URS review, regulatory gap analysis, project charter and validation strategy aligned to your release plan.
DELIVERABLES
›Validation master plan
›Risk register
PHASE · 02
Plan
Validation master plan, C&Q matrices, test strategy, automation FDS/HDS and resource loading by phase.
DELIVERABLES
›C&Q matrix
›Test strategy
PHASE · 03
Engineer
P&IDs, control philosophy, FAT execution, SAT readiness and CSV protocol authoring with traceability.
DELIVERABLES
›FAT/SAT protocols
›CSV protocols
PHASE · 04
Validate
IQ / OQ / PQ execution, deviation management, PV/CPV alignment and integrated commissioning.
DELIVERABLES
›IQ/OQ/PQ packs
›PV / CPV plan
PHASE · 05
Handover
Final validation summary report, regulatory dossier support and post-go-live audit shadowing.
DELIVERABLES
›VSR
›Audit readiness kit
METHODOLOGY · ASTM E2500 · ISPE BASELINE GUIDES RISK-BASED · SCIENCE-LED TRACEABILITY : 100%
06
REGULATORY FLUENCY

Fluent in the frameworks
that govern your release.

Validation is only as useful as the regulator it satisfies. PMBS teams write to the framework your product will be inspected against — and we keep current with each authority's evolving expectations.

R/01 US
  • ·US FDA 21 CFR Part 11
  • ·21 CFR Part 210/211
  • ·cGMP Q7
R/02 EU
  • ·EU GMP Annex 11
  • ·EU GMP Annex 15
  • ·EMA Guidelines
R/03 ICH
  • ·ICH Q7 · GMP for APIs
  • ·ICH Q9 · Quality Risk Mgmt
  • ·ICH Q10 · Pharma Quality
R/04 Industry
  • ·ISPE GAMP 5
  • ·ISPE Baseline Guides
  • ·ASTM E2500
R/05 Global
  • ·WHO TRS
  • ·PIC/S PI 041
  • ·PE 009
R/06 Asia / IN
  • ·CDSCO Schedule M
  • ·MHRA
  • ·PMDA · KFDA
07
CAREERS

Engineers wanted.
Validation leads especially.

PMBS is hiring its founding bench. If you have done the work — IQ-OQ-PQ on a real shop floor, GAMP 5 on a real DCS — we want to talk.

● 6 OPEN POSITIONS
R/01
Lead C&Q Engineer
Lead C&Q programs end-to-end. ASTM E2500 fluency required.
Full-time Bangalore · On-site Apply → R/02
Lead CSV Engineer
Own CSV for DCS/MES/LIMS. GAMP 5 and Part 11 expert.
Full-time Bangalore · On-site Apply → R/03
Process Engineer · USP
P&ID development, scale-up and tech transfer for upstream platforms.
Full-time Bangalore · On-site Apply → R/04
Automation Engineer · DCS
DeltaV or Siemens PCS. Control philosophy and FAT/SAT.
Full-time Bangalore · On-site Apply → R/05
Validation Engineer (IQ/OQ)
2+ years biopharma exposure. Travel up to 50%.
Contract Bangalore · On-site Apply → R/06
Project Procurement Lead
Long-lead biopharma equipment procurement and vendor qualification.
Full-time Bangalore · On-site Apply →
DON'T SEE YOUR ROLE? careers@pm-bs.com
UPDATED · MAY 2026
08
START A PROJECT

Tell us what you're
commissioning.

Scoping in five working days. Drop the project brief below — we'll respond with named leads, a proposed validation strategy and an engagement plan.

REPLY WITHIN 48 HOURS · NDA ON REQUEST