Pharmaceutical Development Program Strategy & Pre-Clinical Clinical Development Regulatory Market Access Commercialization Quality & Compliance Advisory, Transformation & Design
Drug Substance Development (API)
Drug Product Development​
Manufacturing Operations
Manufacturing Compliance
Development Strategy​
Program Evaluation
Non-Clinical Study Execution
Non-Clinical Regulatory Submissions
Non-Clinical Compliance
Clinical Development Strategy
Clinical Operations & Study Management​
Medical Writing & Regulatory Submissions
Clinical Compliance​
Pre-Approval
Authoring, Publishing & Submissions
Post-Approval
Functional Outsourcing
Special Projects
Strategy Development
Achieving Market Access
Artwork & Labeling​
Distribution
Product Release Process
Pre-Approval Inspections & Vendor Audits
Good Laboratory Practice (GLP)
Good Clinical Practice (GCP)
Good Manufacturing Practice (GMP)
Inspection Readiness
Organizational Assessment, Strategy & Design
Implementation, Excellence & Transformation
M&A Regulatory Due Diligence & Integration
Digital Technology Advisory
Select your language
  • Go back
  • Drug Substance Development (API)
  • Drug Product Development​
  • Manufacturing Operations
  • Manufacturing Compliance
  • Go back
  • Development Strategy​
  • Program Evaluation
  • Non-Clinical Study Execution
  • Non-Clinical Regulatory Submissions
  • Non-Clinical Compliance
  • Go back
  • Clinical Development Strategy
  • Clinical Operations & Study Management​
  • Medical Writing & Regulatory Submissions
  • Clinical Compliance​
  • Go back
  • Pre-Approval
  • Authoring, Publishing & Submissions
  • Post-Approval
  • Functional Outsourcing
  • Special Projects
  • Go back
  • Strategy Development
  • Achieving Market Access
  • Go back
  • Artwork & Labeling​
  • Distribution
  • Product Release Process
  • Pre-Approval Inspections & Vendor Audits
  • Go back
  • Good Laboratory Practice (GLP)
  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Inspection Readiness
  • Go back
  • Organizational Assessment, Strategy & Design
  • Implementation, Excellence & Transformation
  • M&A Regulatory Due Diligence & Integration
  • Digital Technology Advisory
    • Contact Us

    Talk to an expert. Get in touch.

    © 2024 G&L Scientific

    Select your language

    Knowledge Hub

    Knowledge Hub Search

    Found 75 results for Regulatory Affairs

    Insights 11 22
    Report

    G&L Insights: Autumn 22 edition

    E CTD baseline submissions
    Blog

    Assessing the value of eCTD baseline submissions

    Outsourcing 3
    Blog

    The benefits of Outsourcing

    Queens Award presentation Peter Griffin Countess Howe
    Article

    G&L honoured with Queen’s Award for Enterprise

    2
    Article

    Mental Health Week 2023: Why Exercise Matters

    Mental Health Week Anxiety
    Article

    Mental Health Week 2023: Anxiety

    4
    Article

    Mental Health Week: The TikTok effect

    SRS Strategy Blog
    Blog

    The importance of a 'living' Regulatory Strategy

    3
    Article

    Mental Health Week: LGBT+ youth facing 'widespread mental health crises'

    Protecting Mental Health
    Article

    Mental Health Week: Protecting and maintaining mental health

    Consultancy Works
    Blog

    Why regulatory consultancy makes sense

    Patient Feedback Blog
    Blog

    Clinical Trials - why the patient's voice matters

    Importation of medicines FDA
    Blog

    Understanding the role of the FDA in the importation of pharmaceutical products

    Physical Eduation Cuts Exercise
    Blog

    Counting the health costs of lack of exercise

    Drug Repurposing
    Blog

    Alzheimer's Disease: why drug repurposing could be the answer

    Outsourcing Makes Sense Blog
    Blog

    Why outsourcing is a worthwhile investment

    Capabilities Gand L Challenges
    Article

    Solutions start here

    Jodi Coates Women in Work summit
    Article

    G&L: Proud advocates of inclusivity and diversity

    Reg Intel Document Story
    Article

    Regulatory and competitor Insights - critical to success

    Dan Flynn Blog PREP
    Blog

    The vital role of Pre-Exposure Prophylaxis in HIV prevention

    AMR website pics 1
    Blog

    WAAW - Day One: The growing concern of Antimicrobial Resistance

    AMR website pics 2
    Blog

    WAAW - Day Two: The risks of AMR

    AMR website pics 3
    Blog

    WAAW - Day Three: Practical steps to reduce AMR

    AMR website pics 4
    Blog

    WAAW - Day Four: Transforming EU legislation: A new era for veterinary medicinal products

    AMR website pics 5
    Blog

    WAAW - Day Five: Presentation by Doctor Sarah Hobson

    TOPRA Blog Part One 1
    Blog

    TOPRA Symposium 2023: Perspectives on new EU regulatory legislation

    TOPRA Big Data
    Blog

    TOPRA Symposium 2023: Big data and regulatory decision-making

    Patient Feedback TOPRA 1
    Blog

    TOPRA Symposium 2023: Patient engagement in medicines’ regulatory lifecycle

    SME Support
    Blog

    TOPRA Symposium 2023: Support and assistance for SMEs

    NPS Score 91
    Article

    Industry-leading NPS for G&L

    New appointments 2024
    Article

    G&L growth continues with two strategic appointments

    Post Approval Support
    Blog

    MHRA introduces new procedures for Marketing Authorisation Applications

    Phil Blog e CTD 4 0
    Blog

    eCTD 4.0: The evolution of regulatory submissions

    Singapore Turlough Blog
    Blog

    The Implementation of eCTD in Singapore

    Submission Readiness
    Blog

    Ensuring submission readiness in eCTD publishing

    E CTD 4 0 Dan Flynn Blog
    Blog

    eCTD 4.0: FDA Implementation Plans

    Gene Therapy Mai Blog
    Blog

    Navigating the gene therapy landscape

    QMS Quality Blog
    Blog

    Developing a fit-for-purpose and phase-appropriate Quality Management System

    Chatbots
    Blog

    Healthcare transformation: Is digital technology the answer to productivity?

    Cancer Research
    Blog

    The impact of FDA’s Project Optimus and Project FrontRunner

    GLHA Focus On CMC Ivan Fisher 1
    Blog

    Manufacturing site rationalization – a regulatory and logistical challenge

    Giannis Blog 2
    Blog

    Understanding the Comparable Overseas Regulator (COR) report-based process

    AI Publishing blog
    Blog

    Understanding the impact of AI on Regulatory Affairs

    Brexit Medicines
    Blog

    Navigating post-Brexit drug regulation: The UK’s path forward amidst political change

    Copy of GLHA Leadership Reflections Bill Griffiths
    Blog

    G&L Leadership Reflections - Navigating biopharma transformation – Bill Griffiths

    GLHA Leadership Reflections Pauk Kuiken
    Blog

    G&L Leadership Reflections - Organization design - Paul Kuiken

    Cert of suitability
    Article

    CEP 2.0 - changes at a glance

    GLHA Leadership Reflections Pauk Kuiken 2
    Blog

    G&L Leadership Reflections - External Consultants - Paul Kuiken

    Digital Tech Week Intro 1200 x 675 px
    Article

    Digital Technology Week: Introduction

    Digital Tech Week Myths
    Article

    Digital Technology Week: Debunking the myths of digital technology

    Digital Tech Week Adoption
    Article

    Digital Technology Week: Digital technology adoption in pharmaceuticals as a precursor for regulatory affairs

    Digital Tech Week Potential
    Article

    Digital Technology Week: Digital technology potential in Regulatory Affairs

    Kings Award Linked In Post
    Article

    King’s Award success for G&L Healthcare Advisors

    Steven Hildemann profile image
    Article

    Dr. Steven Hildemann, MD, PhD, appointed as Non-Executive Director

    Agnes Vet Blog
    Blog

    Understanding the Union Product Database (UPD)

    Richard Edmunds
    Article

    Regulatory expert appointed to lead West Coast US client engagement for G&L

    Smart Step
    Article

    G&L expands global reach and service offering with SmartStep Consulting acquisition

    CIS Region Blog
    Blog

    From complexity to cohesion: EAEU's role in CIS pharmaceutical regulations

    Kevin Webb Website Two
    Article

    G&L appoints Kevin Webb as Chief Growth Officer

    Biocom Panel Discussion
    Article

    G&L Healthcare Advisors to join esteemed panel at Biocom California event

    Blog Staff Augmentation 5
    Blog

    Maximizing efficiency in pharmaceutical regulatory affairs with staff augmentation

    GLHA Leadership Reflections Bill Griffiths Market Access
    Blog

    Development, Regulatory & Market Access strategic alignment – missed opportunities?

    Ellie Mc Dermot blog image
    Blog

    From compliance to innovation – the key changes in pharmaceutical packaging regulations

    COG email headers
    Article

    G&L Healthcare Advisors to participate in Clinical Outsourcing Group Bay Area 2024

    Kings Award 2024 website
    Article

    G&L Healthcare Advisors presented with King’s Award for Enterprise

    2 AMR 2024 Article one
    Blog

    World Antimicrobial Resistance Awareness Week: Educate, advocate, act now

    3 AMR 2024 Article two
    Blog

    Confronting Antimicrobial Resistance: current challenges and strategies

    4 AMR Article three
    Blog

    The One Health approach to combating AMR

    5 AMR 2024 Article four
    Blog

    Latest innovations in AMR diagnosis and mitigation

    Article five
    Blog

    WHO guidance on tackling AMR

    Ben Torrens blog image
    Blog

    The importance of ALCOA++ principles in Pharmaceutical Regulatory Affairs

    Lisa Donaldson blog image
    Blog

    Updates and impacts: Understanding the EMA’s revised guideline on active substances

    Welcome Harry Phil blog
    Article

    G&L commits to further strategic growth with key appointments

    Arun Luckychetty Image Two
    Article

    G&L welcomes Arun Luckychetty as Vice President, Global Head of Business Development

    GL Scientific blog Sarah Imrie 0225
    Blog

    Navigating the EMA’s new fee structure: Strategies to cut costs and stay ahead