Enimera Regs+
Logo Logo Logo Logo
Enimera Regs+
  • Home
  • About
    • About Enimera Regs+
    • Careers
    • Gallery
  • Services
    • Our Services Overview
    • Pharmacovigilance
    • Literature Reviews
    • TGA New Substance Applications (Listed Medicines) and Listed-Assessed Medicines
    • TGA Appeals
    • Medicinal Cannabis
  • GMP LCC Hub
  • Learn
  • Blog
  • Testimonials
  • Resources
  • Contact
  • Home
  • About
    • About Enimera Regs+
    • Careers
    • Gallery
  • Services
    • Our Services Overview
    • Pharmacovigilance
    • Literature Reviews
    • TGA New Substance Applications (Listed Medicines) and Listed-Assessed Medicines
    • TGA Appeals
    • Medicinal Cannabis
  • GMP LCC Hub
  • Learn
  • Blog
  • Testimonials
  • Resources
  • Contact
FDA Shutdown 2025: Impact on Biotech & Pharma Submissions | Enimera RegsPlus
October 13, 2025

The Impact of the 2025 U.S Government Shutdown on FDA Activities: What Biotech and Pharma Need to Know

The U.S. government shutdown that began on October 1, 2025, has created uncertainty across multiple sectors — and the biopharmaceutical

Regulator Interactions
June 19, 2020

Regulator Interactions During COVID-19

How have you managed your interactions with Regulators during this COVID 19 environment? I am excited at the level of research

Global Regulatory
November 15, 2019

Global Regulatory Projects: Best Practices

If you are interested in learning about managing global regulatory projects, or perhaps you currently do work on global regulatory

Medicinal cannabis
June 12, 2019

Medicinal cannabis – How to begin your Regulatory Strategy

Medicinal cannabis refers to a number of different forms of cannabis used for therapeutic purposes.

Medicine shortages
February 13, 2019

What Regulatory Affairs leaders need to consider in relation to medicine shortages….

If you work with OTC or Prescription Medicines, I’m sure you are aware of the TGA mandatory reporting scheme for

Regulatory Strategies
January 22, 2019

What I’ve learnt from preparing Regulatory Strategies – Making the next one even better…

Relief! Your Regulatory Strategy is complete. Now for the feedback, are you ready for it? For my tips on preparing Regulatory Strategies, refer

Preparing Strategies
January 16, 2019

What I’ve learnt from preparing Regulatory Strategies – Now that you’ve started….

So now you really are ready to write that Regulatory Strategy or to present a verbal overview at your next

Preparing Regulatory Strategies
January 9, 2019

What I’ve learnt from preparing Regulatory Strategies – before you begin…

So you’ve been asked to prepare a Regulatory Strategy

Recent Posts

  • The Impact of the 2025 U.S Government Shutdown on FDA Activities: What Biotech and Pharma Need to Know
  • Navigating TGA Pathways for Prescription Medicines in Australia: A Brief Overview
  • What I’ve learnt from preparing Regulatory Strategies Part 1 – 3
  • How has the COVID-19 pandemic impacted Regulatory professionals?
  • BiologicALs vs Biologics – two letters to FMT

Categories

  • Blog
  • Mentoring
  • Online learning
  • Productivity and Effectiveness
  • Regulatory
  • Strategic and Operational Regulatory
  • Translational Research

Tags

#FDApharmaceuticals #shutdownbiotech Biologic Biological Education enimeraregs+ FDA FDA Regulatory Strategy medical device regulatory consulting Medicinal Cannabis Online learning Regulatory Affairs Regulatory Support Strategy TGA TGA Regulatory Matters USGovernmentshutdown

a© Enimera RegPlus Pty Ltd