# REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

> **NIH NIH N02** · CCS ASSOCIATES, INC. · 2023 · $11,246

## Abstract

This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management.

Medical Writing consultants will be responsible for the preparation and submission of high-quality regulatory and other supporting documents for NIH projects. The consultants will coordinate with LDTs to prepare, edit, review, and submit documents to regulatory agencies (e.g., FDA) within project timelines. Documents may include but are not limited to clinical protocols, Investigational New Drug applications (INDs), Investigator Brochures (IBs), IND Amendments, Drug Master Files, and Statement of Investigators (Form FDA 1572) and drug dossiers.

## Key facts

- **NIH application ID:** 10949131
- **Project number:** 75N95023P00808-0-0-2
- **Recipient organization:** CCS ASSOCIATES, INC.
- **Principal Investigator:** LYNN THOMAS
- **Activity code:** N02 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $11,246
- **Award type:** —
- **Project period:** 2023-09-14 → 2024-09-13

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10949131

## Citation

> US National Institutes of Health, RePORTER application 10949131, REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES (75N95023P00808-0-0-2). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10949131. Licensed CC0.

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