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Four Compliance Programs. One Outcome: Inspection Protection.

Schedule M Readiness Training

Revised Schedule M — Clause 11 | Clause 14

Revised Schedule M mandates training effectiveness evaluation — not just attendance documentation. This program closes the gap between your training records and your team's demonstrable competency, producing audit-ready effectiveness evidence that satisfies CDSCO and WHO inspectors.

GMP for Production Teams

WHO TRS 986 | Schedule M Clause 9 | ALCOA

Role-specific GMP training for production operators, packaging staff, and supervisors — delivered in the language of your shopfloor. Covers the 5 GMP behaviors auditors assess during facility walkthroughs, with hands-on documentation error identification exercises.

Every program is anchored to Revised Schedule M, WHO-GMP, and CDSCO inspection realities — not generic regulatory theory.

Deviation & CAPA Workshop

ICH Q10 | Schedule M Clause 20 | WHO Annex 2

The most repeated finding in MSME pharma CDSCO inspections is not the presence of deviations — it is absent or shallow root cause investigation. This workshop builds your QA and production team's ability to identify, investigate, document, and close deviations in a manner that satisfies auditor scrutiny — including CAPA effectiveness verification.

Documentation & Data Integrity

CDSCO Data Integrity Guidance 2019 | WHO TRS 996 | ALCOA+

Data integrity is the fastest-growing category of CDSCO observation. This program addresses the six most common documentation errors that generate regulatory findings — including incorrect correction methods, non-contemporaneous entries, and incomplete batch record practices — using hands-on mock batch record exercises.

Change Control and Pharmaceutical Quality System: Managing Change Without Creating Risk

Change Control System — Planning, Classification, Impact Assessment, Approval, and Documentation

Out-of-Specification Investigation: Laboratory to Batch Release Decision

OOS Investigation — From Initial Result to Final Disposition Decision

Audit Readiness: How to Prepare Your Facility and Your Team for CDSCO and WHO Inspections

Annual Compliance Calendar: Structured Training Partnership for MSME Pharma Manufacturers

Retention and recurring revenue — this is not a single-topic program. It is the packaging of Programs 1–8 into an annual structured engagement.

FSSAI GMP for Nutraceutical Manufacturers: Schedule M Compliance for a Different Product Category

FSSAI GMP Requirements — Specific to Nutraceutical and Dietary Supplement Manufacturing

Change Control System — Planning, Classification, Impact Assessment, Approval, and Documentation