Our Story

Built From the Inside of a Pharmaceutical Facility. Not a Classroom.

We founded Sunfinix Solutions because we witnessed the gap firsthand — between what training records showed and what operators actually knew when an auditor asked.

We Train the Floor. Not Just the File.

Schedule M Clause 11 requires documented training effectiveness — not just attendance records. We deliver both.

When a WHO or CDSCO auditor walks your production floor, they do not ask to see your training register. They ask your operators to explain their procedures — in real time, without prompting. Sunfinix Solution prepares your team for exactly that moment. Our role-specific, on-site training programs are built around the questions auditors actually ask and the knowledge gaps that generate repeat observations.

Our Services

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

Brings years of direct pharmaceutical and excipient manufacturing experience across QA operations, microbiology, production, and food technology functions. She has participated in regulatory audits as a facility team member — not as an external observer — and designs every training program from one question: what will the auditor ask your operator tomorrow, and can they answer it without hesitation?

Harshal combines pharmaceutical domain knowledge with deep expertise in the MSME manufacturing ecosystem of the Vapi–Daman–Silvassa corridor. He specializes in Revised Schedule M compliance strategy and builds the client engagement systems that connect Sunfinix Solution programs to the facilities that need them most.

Our Founders

DRx. Kalyani Rajput

Lead Trainer & Program Director

DRx. Harshal Rajput

Co-Founder & Business Development

B.Pharm | MBA (Marketing) | QA & Production Experience | Microbiology Operations | Regulatory Audit Participant

B.Pharm | Revised Schedule M Specialist | MSME Pharma Corridor Expert | Compliance Readiness Systems

Why MSME Pharma Manufacturers in the Vapi–Daman Corridor Choose Sunfinix Solution

Clause 11

Every program produces Schedule M-compliant training effectiveness documentation — not just attendance records.

All programs conducted at your facility — in Hindi, Gujarati, Marathi or English based on your floor team's working language.

Post-training competency assessment report delivered within 24 hours — your audit-ready effectiveness evidence.

On-Site Delivery

24-Hour Report

Engagement Programs

Three ways to build inspection readiness into your facility — from a single focused session to a full annual compliance calendar.

Pilot Session

A focused 2-hour on-site session covering your single highest-risk compliance gap. Includes post-training competency assessment and effectiveness report

Schedule M Readiness Program

Three structured sessions over 60 days — covering your facility's specific Schedule M gaps identified through our readiness assessment. Full competency documentation included.

Annual Compliance Calendar

Twelve-month training program covering all Schedule M Clause 11 requirements. Monthly or quarterly delivery. Ongoing compliance advisory included.

Stay inspection-ready

Your Next CDSCO Inspection Does Not Wait for You to Be Ready.

Start with a free Schedule M Readiness Assessment — 15 questions, 10 minutes, identifies your highest-risk gaps before an auditor does.

CONTACT

Initiate a Schedule M Readiness

We respond to all facility inquiries within one business day. Our first conversation is a diagnostic — not a sales call.

Reach out to us

Our Hub

Sunfinix Solution delivers on-site compliance training exclusively within the Vapi–Daman–Silvassa–Sarigam–Ankleshwar corridor — the region that accounts for a significant share of India's MSME pharmaceutical manufacturing and export capacity.

Address

Sunfinix Solution LLP, Silvassa, D&NH, DD — 396230

Hours

Mon-Sat 9am-6pm

Operating in India's Highest-Density Pharmaceutical Manufacturing Corridor

Sunfinix Solution LLP, Silvassa, D&NH, DD