Swiss-Grade Compliance for Global Market Access: Bridging India and Africa to the World.

In the high-stakes world of pharmaceutical export, your production license is only as strong as your last international inspection. I provide the strategic architecture to align manufacturing facilities in India, Africa, and beyond with the most rigorous global standards. Whether you are targeting the US under FDA 21 CFR, Europe via EMA EU-GMP, or the Swiss market, I ensure your system is built for total regulatory confidence.

Futuristic digital cityscape with interconnected glass bridges, modern buildings, and holographic interface displaying 'FDA', 'EMA', and 'WHO'.
A digital badge with a padlock icon and the text "Data Integrity" overlaid on a laboratory setting, emphasizing US-FDA compliance and digital monitoring.

US-FDA Readiness (21 CFR Part 211 & 11)

Navigating the US market requires more than just meeting GMP; it requires a documented "Quality Culture." I specialize in preparing global manufacturers for the scrutiny of the FDA. My approach focuses on scientifically sound investigations, robust Deviation Management systems, and strict adherence to 21 CFR Part 11 for electronic records. We don't just avoid Warning Letters; we build systems that auditors respect.

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EMA & Swissmedic Harmonization

European and Swiss authorities emphasize the "Life-Cycle Approach." From Annex 1 (Sterile Manufacturing) to Annex 15 (Qualification and Validation), I help you implement European standards without drowning in bureaucracy. By harmonizing EMA and Swissmedic requirements, we create a lean, single-source QMS that serves all Western inspectorates.

A high-tech warehouse with shelves of boxes, workers in lab coats using control panels, and a digital globe with a shield labeled 'World-Class Quality' in front of large windows showing a city skyline at sunset.

PICS & WHO Excellence

For manufacturers aiming for international tenders, aligning with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and WHO pre-qualification is essential. I leverage my 30 years of inspection experience to simplify the path to these global certifications, ensuring your facility is recognized as a world-class manufacturing hub.

  • Yes. Through "Integrated Compliance Architecture," we identify the most stringent requirements across FDA 21 CFR and EU-GMP Vol. 4. We build a core documentation set that addresses the "Highest Common Denominator," reducing document duplication by up to 30% while maintaining full global readiness.iption text goes here

  • Data Integrity is the most common reason for failed audits in emerging markets. I implement technical and organizational controls to ensure data is Attributable, Legible, Contemporaneous, Original, and Accurate. We focus on "Audit Trail Reviews" and system-level security to prevent regulatory findings before they happen.