Generative AI, Agentic Systems, and the Future of Medical Writing
Not long ago, the idea of artificial intelligence drafting a clinical study report would have been dismissed outright. Today, it is a live conversation across pharmaceutical and biotech organizations. Industry surveys suggest that roughly a third of medical writing organizations are already piloting AI tools, with another fifth actively exploring use cases [1]. Generative AI, broadly defined as large language models …
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Why High Quality Module 2.4 and 2.6 Summaries Are Essential for IND and NDA Success — and How Intrinsik Delivers Them
A successful Investigational New Drug (IND) or New Drug Application (NDA) submission depends heavily on the clarity and credibility of the Sponsor’s nonclinical narrative. Many organizations underestimate the importance of integrating data across Chemistry, Manufacturing, and Control (CMC), safety pharmacology, drug metabolism and pharmacokinetics (DMPK), and toxicology disciplines. Without this alignment, Module 2 summaries can …
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How Expert Module 2.4 and 2.6 Authoring Reduces Regulatory Risk — Intrinsik’s Proven Approach
High‑quality Module 2.4 and 2.6 summaries provide much greater value than simply restating nonclinical results. When authored by an experienced team, these modules provide a strategic scientific argument that supports clinical trial design, protects overall development timelines, and demonstrates regulatory readiness. A strong Module 2.4 weaves pharmacology, safety pharmacology, pharmacokinetics, and toxicology data into an …
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Understanding the ICH Q3E Draft Guideline: Strengthening Extractables & Leachables Programs with Science Driven Toxicological Insight
The ICH Q3E Draft Guideline for Extractables and Leachables represents a step toward global harmonization in how the pharmaceutical industry evaluates and controls chemical species that may migrate from packaging, manufacturing components, or delivery systems into drug products. As therapies become more advanced and delivery systems more intricate, the need for a consistent, risk‑based approach …
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Intrinsik’s What’s New – 3rd Regulatory Edition 2025 – Health Canada and FDA Updates
Intrinsik’s What’s New – 3rd Regulatory Edition 2025 – Health Canada and FDA Update What’s New Regulatory Edition FDA Updates Guidance Documents 1.Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations This draft guidance [issued July 3, 2025] is intended to clarify the key factors in calculating …
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Intrinsik’s What’s New – 2nd Regulatory Edition 2025 – Health Canada and FDA Updates
Intrinsik’s What’s New – 2nd Regulatory Edition 2025 – Health Canada and FDA Updates What’s New Regulatory Edition FDA Updates Guidance Documents Study Data Technical Conformance Guide – Technical Specifications Document This final guidance [Version 6.0, dated March 2025] provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data …
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Navigating Submissions Relying on Third-Party Data (SRTD) in Canada: A Strategic Guide for Pharmaceutical Companies
Expert regulatory guidance from Intrinsik Corp. Streamlining your path to Canadian market approval What is an SRTD? Since 2015, Health Canada’s Submission Relying on Third-Party Data (SRTD) pathway offers pharmaceutical companies a potentially cost-effective alternative to traditional New Drug Submissions (NDS). Instead of conducting extensive original clinical trials, SRTDs leverage published literature and market experience …
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What’s New – Regulatory Edition – Health Canada and FDA Updates
What’s New – Regulatory Edition – Health Canada and FDA Updates What’s New Regulatory Edition FDA Updates General Notices FDA qualifies drug development tool to facilitate clinical trial research on alcohol use disorder FDA’s Center for Drug Evaluation and Research (CDER) has a qualifying tool to support the development of treatments for alcohol use disorder …
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Health Canada’s PRCI Process – A Deep Drive into Transparency
Transparency in the approval and regulation of health products is crucial for maintaining public trust, ensuring patient safety, and enabling informed decision-making. Health Canada has taken significant advances toward ensuring transparency in its drug approval process. One of the key initiatives in this effort is the Public Release of Clinical Information (PRCI) process. This process …
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ICH M4Q(R2): An Update from ICH and CAPRA
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a key role in global pharmaceutical regulatory alignment. The ICH M4Q(R2) guideline, a revision of the M4Q(1) (2002) guideline, aims to improve the efficiency of pharmaceutical submissions and lifecycle management. M4Q(R2) includes a restructuring of Module 2 and Module 3 …
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Updates to Health Canada’s Quality Guidance: New Drug Submissions and Abbreviated New Drug Submissions (December 2024)
Health Canada has introduced significant updates to its Quality (Chemistry and Manufacturing) Guidance for New Drug Submissions and Abbreviated New Drug Submissions. These changes, effective December 2024, are part of Health Canada’s modernization work and reflect changes in regulatory expectations since the 2018 version. The following key updates have been introduced: Nitrosamine Risk Assessment (S.3.2, …
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Why and How – Health Canada Master Files
The Master File (MF), formerly Drug Master File (DMF), is a regulatory filing used to provide supporting submission information to Health Canada, without revealing the contents to the sponsor of the drug submission. Health Canada is bound to protect the confidential business information (CBI) in the MF in compliance with the Food and Drugs Act …
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Acceptable Intake Limits Now More Clearly Defined for Nitrosamine Impurities and Nitrosamine Drug Substance-Related Impurities (NDSRIs)
Nitrosamines are a class of compounds with the chemical structure shown in Figure 1. In the International Council for Harmonisation (ICH) M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk guidance document (ICH 2018), nitrosamine compounds were identified as a “cohort of concern” based on potent genotoxicity observed …
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Ethylene Glycol and Diethylene Glycol Contamination Risks and FDA’s New Guidance on Testing in High-Risk Drug Components
The FDA has recently issued new guidance for the pharmaceutical industry regarding the testing of ethylene glycol (EG) and diethylene glycol (DEG) in high-risk drug components in response to recent reports of fatal poisoning from DEG- or EG-contaminated oral liquid drug products1. In early 2023, the World Health Organization (WHO) issued worldwide health alerts regarding …
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Priority Review vs NOC/c – Which Pathway is Right for Me?
Drug development and innovation is incredibly important to those with life-threatening and severely debilitating conditions. The process of getting a drug from discovery to the market is lengthy, taking an average of 10 years. However, expediting the process is difficult, as research and clinical trials take up a significant amount of time and cannot be …
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