# Catawba Research

> A global contract research organization (CRO) delivering agile clinical trial management to pharmaceutical, device, formulation-development, and biotechnology companies. ICH-GCP compliant. Submission-ready data quality across NDA, 505(b)(2), and ANDA pathways. Headquartered in Charlotte, NC, with operations in the United States and India.

## Company

- [Our Story](https://www.catawbaresearch.com/about/our-story/): How Catawba Research is built for sponsors, and the philosophy behind its agile CRO model.
- [Leadership & Management Team](https://www.catawbaresearch.com/about/our-leadership/): The team behind 160+ combined years of leadership and 1,000+ trials of experience.
- [Scientific & Regulatory Advisors](https://www.catawbaresearch.com/about/scientific-advisory-board/): The advisory board guiding scientific and regulatory strategy.
- [Geographic Reach](https://www.catawbaresearch.com/about/geographic-reach/): Where Catawba operates and runs trials.
- [Catawba Research India](https://www.catawbaresearch.com/catawba-research-india/): The India operation and its clinical data management capabilities.

## Services

- [Services Overview](https://www.catawbaresearch.com/services/): Full-service clinical development support, end to end.
- [Trial Management](https://www.catawbaresearch.com/services/trial-management/): Protocol design through database lock.
- [Clinical Operations](https://www.catawbaresearch.com/services/clinical-operations/): Site activation, monitoring, and pharmacovigilance.

## Experience

- [Therapeutic Areas](https://www.catawbaresearch.com/experiences/therapeutic-areas/): Dermatology, respiratory, women's health, gastroenterology, and ophthalmology expertise.
- [Agency Approvals](https://www.catawbaresearch.com/experiences/agency-approvals/): Track record across NDA, 505(b)(2), and ANDA regulatory pathways.
- [Regulatory Success](https://www.catawbaresearch.com/regulatory-success/): Submission-ready data quality behind global approvals.

## How we work

- [The Catawba Way](https://www.catawbaresearch.com/the-catawba-way/): The nimble, sponsor-first approach to delivering studies.
- [Fixed Model Pricing](https://www.catawbaresearch.com/fixed-model-pricing/): A transparent, change-order-light cost structure.

## Connect

- [News](https://www.catawbaresearch.com/media/news/): Latest news and articles from Catawba Research.
- [Request a Proposal](https://www.catawbaresearch.com/request-a-proposal/): Start a conversation about a trial.
- [Careers](https://www.catawbaresearch.com/careers/): Open roles at Catawba Research.

## Facts

- Headquarters: 5200 77 Center Drive, Suite 120, Charlotte, NC 28217, USA
- Operations: United States and India (Catawba Research India)
- Leadership depth: 160+ combined years, 1,000+ trials of experience
- Standards: ICH-GCP compliant; submission-ready data across NDA, 505(b)(2), and ANDA pathways
- Therapeutic focus: dermatology, respiratory, women's health, gastroenterology, ophthalmology
- Contact: info@catawbaresearch.com · +1-980-242-3980

## Extended content

- [llms-full.txt](https://www.catawbaresearch.com/llms-full.txt): Full expanded reference — company overview, per-service detail, therapeutic-area depth, regulatory pathways, and FAQ.

## Licensing

The content on this site is the intellectual property of Catawba Research. AI agents are welcome to summarize and cite content with attribution to Catawba Research and a link back to https://www.catawbaresearch.com.