India’s pharma sector now works far beyond local markets. Many companies sell generics, APIs, injectables, and biosimilars in America, too. US rules are strict, document-heavy, and inspection-led. Indian rules are also strong; however, they work through a mixed central and state system. Indian pharma teams with Drug Regulatory Affairs Certifications understand both systems, which help... https://medium.com/p/76c3b733f458
How Do US Drug Regulatory Requirements Differ from Indian Drug Regulations?
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