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This article talks about the US FDA issued guidance on control of nitrosamine impurities in human drugs & APIs for manufacturers to ensure safety supply of drug products.
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This article talks about the Regulatory updates on pharmaceutical industry for medicinal products manufacturers who are willing to market their products across Europe.
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This article talks about the South Korea’s MFDS released draft guidelines detailing safety rules for personalized/custom cosmetics manufacturers.
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This article talks about the EMA’s temporary updated guidance on GMP(Good Manufacturing Practices) and GDP(Good Distribution Practices) regulatory flexibilities for quick market entry of medicinal products during Covid-19 pandemic.
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Freyr provides Regulatory Affairs services to Pharmaceutical Companies for drug classifications, drug registrations, licensing and obtaining market approvals with focus on the entire Pharmaceutical Regulatory Affairs value-chain.
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Freyr Provides Regulatory Affairs Services to Generic drug companies that span across lifecycle management, generic Regulatory CMC, post-approval submissions, annual reports, renewals, compilation and submission for already approved NDAs/MAAs/ANDSs/Dossiers/DMFs/CEPs.
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Freyr provides Regulatory Affairs services to the biologics medicinal products during market authorization, lifecycle management (LCM) support, HA regulatory requirements and Global registration support.
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Freyr Provides global Regulatory Affairs Services to Pharma, Biotech and Bio-Med companies to comply with Health Authority regulatory requirements.
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