Pharma 4.0: what is the Next future in Pharmaceutical Manufacturing Pharma 4.0 represents the integration of advanced technologies such as Artificial Intelligence (AI), Internet of Things (IoT), and Big Data Analytics into pharmaceutical manufacturing,...
News Articles / Regulatory affairs
by samitfm · Published July 8, 2024 · Last modified January 8, 2025
What is stability testing of new drug substances and products Stability testing of new drug substances and products the purpose of this communication is to detail the updates incorporated in Q1A(R) following the adoption...
News Articles / Regulatory affairs
by samitfm · Published July 3, 2024 · Last modified January 8, 2025
Procedure for export of Indian drug product in overseas market Procedure for export of pharmaceutical products Background pharmaceutical Procedure for export of pharmaceutical Indian drug product in overseas market India holds a prominent position...
News Articles / Regulatory affairs
by samitfm · Published July 2, 2024 · Last modified January 8, 2025
Overview of Regulatory authorities and agencies of (Organization structure and types of applications): India United States European Union Australia Japan Canada Background Regulatory authorities and agencies Regulatory affairs in the pharmaceutical industry focus on...
Abbreviated New Drug Application (ANDA) Abbreviated New Drug Application An abbreviated new drug application (ANDA) is submitted to the FDA for review and potential approval of a generic drug, allowing the applicant to manufacture...
New Drug Application (NDA) & Requirements crucial document to submit USFDA New Drug Application For many decades, the regulation and oversight of new drugs in the United States have centered around the New Drug...
Investigational New Drug (IND) approval processes and time-lines involved. Investigational New Drug Current federal law mandates that a drug must have an approved marketing application before it can be transported or distributed across state...
News Articles / Regulatory affairs
by samitfm · Published June 29, 2024 · Last modified January 8, 2025
Regulatory Approval Process for Investigational New Drug (NDA-24) Investigational New Drug Background Investigational New Drug Investigational New Drug The drug approval process involves a regulatory pathway through which individuals, organizations, sponsors, or innovators obtain...
loan license to obtain in India, medical device manufacturers must adhere to regulatory requirements. A loan license in the context of medical devices involves an arrangement where a company without manufacturing capabilities can partner...
Curie.Bio Secures $380M in Series A Funding to Advance Biotech Startups to Clinical Stage Curie.Bio incubator has successfully secured $380 million for its latest fund, aimed at supporting startup companies as they progress toward...
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At Zaims Pharma, we focus on the intersection of pharmaceutical regulations, compliance standards, and the transformative power of technology. Our team is passionate about simplifying the complexities of the industry, whether through in-depth articles, expert interviews, regulatory updates, or software solution reviews. We provide valuable tools and actionable insights that help our readers navigate the evolving landscape of pharmaceuticals and healthcare.
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