FOUNDER & STRATEGIC QA LEADER & PHARMA QUALITY CONSULTANT

With corporate Quality Assurance experience at top-tier organizations like Alkem Laboratories, Panacea Biotech and Fresenius Kabi Oncology, I founded First-Time Right Compliance Solutions to provide site leadership with uncompromised regulatory strategy. Specializing in high-risk Oncology pilot plants and Sterile Injectable facilities, ensuring that when global regulators arrive, your site is prepared and resilient.

17+ Years of Leadership

The SANNARCH Legacy: Traditional Rigor Meets AI-Intelligence

The journey of First-Time Right Compliance Solutions is defined by a relentless pursuit of 'First-Time Right' compliance. Our team has steered global pharmaceutical giants through the most complex regulatory landscapes, successfully clearing 5+ critical USFDA and MHRA inspections with impeccable records.

Corporate QA Leadership across multi-site operations Elite Regulatory Readiness for USFDA/MHRA audits AI-driven Validation Systems for modern healthcare

5+ USFDA Inspections Cleared

With 17+ years of leadership in corporate quality assurance, our team bridges the gap between traditional pharmaceutical rigor and AI-driven intelligence. We focus on 'First-Time Right' compliance to ensure your operations are consistently USFDA, MHRA, and EMA inspection-ready.

Compliance is not just a regulatory hurdle; it is the foundation of digital innovation. Our mission is to secure that foundation with absolute precision and AI-driven foresight.

— CEO, First-Time Right Compliance Solutions

The Methodology

PREDICTIVE DIGITAL COMPLIANCE

In an era of increasing USFDA and MHRA scrutiny, traditional Quality Assurance is no longer enough. We provide high-stakes Subject Matter Expertise to transition sites from legacy paper systems to AI-integrated operations.

21 CFR Part 11 Validation: Ensuring automated workflows (TrackWise, SAP, LIMS) meet global data integrity standards.
Sterile & Oncology SME: Expert oversight for high-risk aseptic fill-finish and lyophilization lines.

CORE COMPETENCIES

Regulatory Readiness

Mastery in USFDA & MHRA Mock Audits. We conduct deep-dive, on-site gap analyses for OSD and Sterile lines before regulators arrive.

CAPA Remediation

Strategic response drafting, root cause investigations, and on-site implementation tracking for Form 483s and Warning Letters.

Facility Validation

Review and approval of critical Validation Protocols (IQ/OQ/PQ), BMRs, MFRs, and strict global Vendor Governance.

Policy Guidelines

COMMERCIAL TERMS & POLICY

Financial Terms

Structured to ensure seamless project initiation and transparent billing for high-stakes corporate engagements.

Advance Payment

A 50% mobilization fee is required for projects exceeding INR 1,00,000.

Balance Payment

Remaining balance is strictly due within 15 days of final deliverable submission.

Taxes

All professional fees are exclusive of applicable GST.

Engagement Rules

Designed to protect proprietary pharmaceutical processes and ensure on-site operational efficiency.

Travel & Expenses

Lodging (4-star min) and local transport for visits outside HQ billed at actuals.

Confidentiality

Every engagement is subject to a mutual Non-Disclosure Agreement (NDA).

Standard Day

A consulting day constitutes 8 working hours.