medical documentation, regulatory strategy, & more

Industries We Serve:

Small Molecules

Here’s How We Can Help

While drug formulations and mechanisms of action change over time, submission data and documentation requirements remain unwavering.  Our CMC, regulatory strategists, and project managers can help with your:

  • Antivirals
  • Antibody-drug conjugates
  • Synthetic hormones
  • Enzyme inhibitors
  • Receptor agonists/antagonists
  • Ion channel modulators
medical documentation
medical documentation

Delivering Regulatory Services that Make a Real Difference.

Regulatory Writing

Our experienced in-house writers deliver precise, compliant, and high-quality regulatory documents. We offer a full suite of writing services to cover all your document needs.

Consulting Services

Our team's deep industry knowledge and regulatory expertise help you navigate the complex requirements and optimize your regulatory strategies.

Additional Services

We tailor our services to meet the unique needs of each client, providing flexible and scalable solutions.

GLOBAL Resources

Recent Blogs

IND vs. NDA: Understanding the Difference in FDA Submissions

For drug developers, FDA approval is a long and complex journey. Two of the most important milestones on this path are the Investigational New Drug (IND) application and the New Drug Application (NDA). While both are critical submissions, they serve very different purposes.

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The FDA’s CMC Development and Readiness Pilot (CDRP) Program: What Sponsors Need to Know

In August 2023, the U.S. Food and Drug Administration (FDA) announced the launch of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program. This initiative is designed to help sponsors of certain accelerated development products better align their CMC strategies with the FDA early in the development process.

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CMC Challenges in Cell & Gene Therapy: How to Avoid Regulatory Delays

In recent years, cell and gene therapies (CGTs) have transformed from scientific breakthroughs into commercial realities. These advanced modalities are redefining how we approach rare, genetic, and otherwise untreatable diseases—offering patients options that were once unimaginable. Yet, while the science is groundbreaking, the CMC (Chemistry, Manufacturing, and Controls) pathway remains one of the most significant obstacles to timely regulatory approval.

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GLOBAL provides trusted regulatory consulting , writing, and technology solutions to help manufacturers bring products to patients at a life saving pace. We’ll be with you every step of the way.

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