Pharma & Biologics Regulatory Submissions

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medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
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What is a Clinical Study Report (CSR)?

Understand what a Clinical Study Report (CSR) is and why it’s critical for regulatory submission. Learn how the ICH E3 guideline shapes its structure and how expert medical writing ensures clarity, compliance, and approval-readiness.

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medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

The CTA Process Under Regulation (EU) 536/2014

European Commission, Regulation (EU) No. 536/2014 is challenging the status quo when it comes to clinical trial writing solutions.

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medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

Tips for a Successful eCTD Submission

Explore tips from the GLOBAL team for a successful eCTD submission.

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medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

IND Submission Consulting Top Tips with Julie Moon

We sat down with Julie Moon, an expert in CMC and our BD Director. She shares top tips for a successful IND submission.

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medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

How Do You Know When You’re Ready to Submit an IND? Part 2

How to determine if you need a pre IND meeting, how to prepare, and other ideas to move forward with confidence.

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medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

How Do You Know When You’re Ready to Submit an IND? Part 1

Read about the core requirements for a successful IND submission, the strategic advantages of scheduling a pre-IND meeting, and how to prepare in a way that not only streamlines the review process but also reduces the risk of encountering a clinical hold.

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medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

GDUFA: Its impact on the Type II Drug Substance Drug Master File (DMF)

This post highlights some FDA initiatives undertaken to enhance the DMF review process and provide guidance to the pharmaceutical industry, in light of GDUFA.

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medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

A Clear Path to the Clinic and Beyond: Why It Matters to Get Your IND Submission Right

Tips on how to avoid submission delays and improve your IND submission process.

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