“Your passport to global pharmaceutical export compliance.”
Hippocratic Pharma Research (HPR) offers a complete regulatory passport for pharmaceutical companies looking to export Active Pharmaceutical Ingredients (APIs) and finished drugs worldwide. The global market requires navigating complex, constantly changing laws, but HPR simplifies this entire process. We act as your strategic regulatory partner, providing end-to-end guidance—from initial market research to final product registration—to ensure your products achieve seamless and fully compliant entry into international markets. This allows your team to focus entirely on innovation and growth.
We specialize in translating complex international rules (like those from the CDSCO/US-FDA/EMA) into clear, actionable export strategies. HPR manages all critical documentation, including preparing comprehensive dossiers (such as the CTD) and securing essential certifications like the Certificate of Pharmaceutical Product (COPP) and Good Manufacturing Practices (GMP) adherence. Beyond submission, we provide ongoing support for quality assurance, post-approval changes, and preparation for global regulatory inspections, ensuring you mitigate risk, accelerate approval timelines, and build credibility with international health authorities.
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