Health Impact Assessment in Canada – Frequently Asked Questions Answered
Blog Overview The following blog provides a concise, practical introduction to Health Impact Assessments (HIAs) and their growing role in project planning and decision-making across Canada. It explains how HIAs offer a systematic, evidence-based approach to evaluating both the positive and negative effects of projects, policies, and developments on community health, while also considering how …
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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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Navigating Brownfields in Ontario: An Overview of Ontario Regulation 153/04 Risk Assessments and Due Diligence Risk Assessments
Blog Overview Risk assessment plays a critical role in managing contaminated sites, including brownfields, and supporting property transactions in Ontario. Under Ontario Regulation 153/04 (O. Reg. 153/04), risk assessments are a formal, science-based process used to evaluate potential risks to human health and the environment in support of a Record of Site Condition (RSC). In …
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Digging for Answers in Ontario’s On-Site and Excess Soil Management Regulation (Ontario Regulation 406/19) and Excess Soil Risk Assessment
Digging for Answers in Ontario’s On-Site and Excess Soil Management Regulation (Ontario Regulation 406/19) and Excess Soil Risk Assessment Blog Overview Ontario’s On-Site and Excess Soil Management Regulation (O. Reg. 406/19) has significantly changed how excess soil is characterized, managed, and reused across the province. Introduced to promote responsible soil management and increase beneficial reuse …
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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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Changes to Alberta Tier 1 Soil and Groundwater Remediation Guidelines for Human Health for Dioxins and Furans Explained
Alberta Environment and Protected Areas (EPA) released an update to the Alberta Tier 1 Soil and Groundwater Remediation Guidelines on June 27, 2024. As part of that update, changes were made to the Alberta Tier 1 Soil and Groundwater Remediation Guidelines for dioxins and furans. The changes are based on the findings of a panel …
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