Revised Schedule M · for pharma manufacturers
Orthic helps small and mid-sized pharma manufacturers find their Schedule M gaps, fix them in a planned 60–90 day Sprint, and keep the evidence in one place with a tamper-evident audit trail.
Starting with manufacturers in Baddi, then Gujarat and Maharashtra.
Why now
Revised Schedule M raised the GMP bar for every licensed manufacturer. Small and medium manufacturers, with turnover up to ₹250 crore, that filed an upgrade plan were given until 31 December 2025. That date has passed.
Many gaps aren’t about new machines. They sit in documents, records and habits, and most can be found in a diagnostic and planned into a Sprint.
Source: Ministry of Health and Family Welfare, PIB release, February 2025.
Offers
Most plants start with a diagnostic. It tells you what is missing and what it will take, before you commit to anything bigger.
A plant visit and a document review against revised Schedule M. You get a written gap report with every finding ranked by risk, and a costed plan to close them.
The full fee is credited if you go on to a Sprint.
Book a diagnostic call60–90 days to close the gaps from the diagnostic. We work alongside your QA team on SOPs, CAPAs, qualification and validation records, training and mock audits.
A written progress update every week.
Talk about a SprintOne place for CAPAs, evidence and document control. Every entry goes into a tamper-evident audit trail, so you can show who changed what, and when.
One facility, two users.
Ask for a demoWe don’t promise inspection outcomes or certification. That decision always rests with the regulator. We help you close the gaps and keep the evidence.
How the diagnostic works
We learn about your plant, dosage forms and recent inspection history, and you decide whether a diagnostic makes sense.
A fixed fee and scope in writing, plus a mutual NDA before we see any document.
You share your quality manual, SOP index, recent CAPAs and validation master plan. We read them before the visit.
On site, we walk the areas, check records at the point of use and speak with QA, QC and production.
Within 10 working days of the visit: every gap mapped to its Schedule M requirement, ranked by risk, with the effort needed to close it.
A call with your team on the report. If you choose a Sprint, the diagnostic fee is credited in full.
Who we work with
About
Arjun grew up between Mumbai, Lagos, Istanbul and Madison and studied economics and political science at the University of Wisconsin–Madison. He started Orthic in 2026 to bring small and mid-sized pharma manufacturers the structured quality work that large companies get from in-house teams.
We are building a small team of experienced QA practitioners and engineers to work alongside plant teams.
Questions
No. Nobody can honestly promise that. We find the gaps, help you close them and keep the evidence ready for the inspector.
No. We work alongside them, and the SOPs and records we help write stay yours.
We sign a mutual NDA before we see any document. Orthic software records every change in a tamper-evident audit trail, so you can see who changed what, and when.
No. You keep the gap report and the plan. If you continue, the fee is credited to the Sprint.
Contact
Tell us where the plant is, what you make and what prompted you to get in touch. Arjun replies within one working day.
arjun.akshikar2@gmail.comUseful to include: plant location, dosage forms, your role, and any recent inspection observation or NSQ report.