Pharma & Nutraceuticals (Manufacturing)

Schedule M, DPCO, CDSCO and FSSAI compliance on a calendar

Compliance runs on one person's memory and a wall calendar. A drug-licence or FSSAI renewal lapses, a stability schedule slips, a narcotic register falls behind, a DPCO price-change notification is missed, and the exposure is a stopped plant, a penalty, or a legal event, not just a fine. When a drug inspector or an auditor asks for evidence, it is a scramble across folders.

Who has it

Across all segments, with different load: formulation manufacturers and contract and loan-licence makers carry Schedule M, drug licences, DPCO, narcotic registers and stability; API and intermediates makers carry factory, pollution-board, narcotic-precursor and export DMF and COS obligations; nutraceutical and supplement producers carry FSSAI nutraceutical and label-claim obligations.

What we build

A deadline-driven compliance calendar with named owners and escalations covering Schedule M (GMP) obligations, drug-licence and FSSAI renewals, stability-study schedules, the narcotic and psychotropic register cadence, DPCO ceiling and price-change tracking, and export obligations (DMF, COS) where they apply, plus a complete, retrievable audit trail. Filings and dispositions stay human-prepared and human-signed.

What is automated, where AI helps, who signs off

Automation for the routine. A person on every decision that matters.

The reliable spine

The non-AI spine is the source-linked workflow: clean records, rules, calculations, integrations, exception queues, approvals and reporting for Schedule M, DPCO, CDSCO and FSSAI compliance on a calendar.

Where AI helps

AI is limited to bounded reading, extraction, matching, clustering or drafting from the firm's own data for Schedule M, DPCO, CDSCO and FSSAI compliance on a calendar; it never owns the number, the approval, the promise or the decision.

Who signs off

A named person signs off anything touching money, stock, a customer promise, a regulated filing, a payment, a price, a credit decision or a people decision.

What changes day to day

Renewals, stability schedules and registers run to a calendar with a named owner instead of to memory; filings stop slipping; evidence is retrievable in minutes; regulation becomes a managed, provable strength.

Illustrative outcome

Zero lapsed licences, renewals or stability milestones across a cycle, and audit evidence retrievable in minutes. Illustrative; final numbers come from your own data.

Illustrative; final numbers come from your own data.

Path to the build

How this one gets built.

Book a free 60-minute call, then a free Blueprint on the firm's own records. Deep-dive and build, followed by run and govern so the workflow keeps paying back.

Find the one build worth funding first.

A free 60-minute call. No cost, no obligation, just a clear read on what is worth building.