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Articles by Satish Joshi
09.24.24 -- 2024 Emerging Trends In Cleanroom Technologies
By Damini Pawar, senior associate – healthcare, MarketsandMarkets This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more. By Ajay Pazhayattil, Satish Joshi, and Marzena Ingram A comprehensive review of FDA observations from small molecule drug facilities sheds light on the state of compliance and regulatory practices in the pharma industry.
09.14.24 -- Pharmaceutical Online Best Of August
AUGUST'S BEST FEATURED EDITORIAL 2023–2024 Trends In FDA Form 483s For Pharmaceutical Formulation Facilities A comprehensive review of FDA observations from small molecule drug facilities sheds light on the state of compliance and regulatory practices in the pharma industry. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July.
08.14.24 -- A Day In The Life Of A CMC Professional
With over 35 years’ experience in the medtech, diagnostics, and pharmaceutical markets, SMC Ltd. provides in-house engineering, injection molding, assembly, fill finish, device manufacturing, packaging services, and can manage sterilization. Our customers rely on us for speed-to-market and our program management process is a key to well managed projects. With inhouse global supply chain expertise, we help customers reduce risk while maintaining tight timeframes.
2023–2024 Trends In FDA Form 483s For Pharmaceutical Formulation Facilities Original
By Ajay Pazhayattil, Satish Joshi, and Marzena Ingram Insights from FDA inspection trends serve as valuable resources for understanding regulatory focus areas and identifying potential vulnerabilities within quality systems. The publicly available inspection observation data provide a strong rationale for immediately addressing many of the challenges faced by manufacturers of FDA-regulated drug products.
Pricing Your Outsourcing Contract in Uncertainty
A study examines the impact that volatility and ambiguity can have on whether a fixed-price or cost-plus contract provides greater benefit in strategic outsourcing agreements. Companies in a global economy are increasingly involved in strategic outsourcing contracts that require joint efforts by vendors and clients. These agreements often involve uncertainty that creates contracting challenges.
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