SAFC Pharma - Small Molecule - Regulatory Compliance

Introduction

Services Overview

Drug Discovery

Preclinical Development

Clinical Scale-up and Supply

Commercial Supply

Raw Materials & Intermediates

Project Management

Regulatory Compliance

Facilities

Specialized Technologies

Regulatory Compliance
	Small Molecule Services

SAFC has an experienced regulatory team that works to aid customer requirements for development programs (DMF/CMC) as well as SAFC's global regulatory compliance needs for drug substance manufacturing. SAFC has a solid regulatory history and maintains multiple FDA inspected facilities around the world.

Services Overview
	Experienced regulatory staff with a track record of successful submissions
	93 Active DMFs worldwide
	35 Commercial APIs
	Excellent FDA regulatory inspection record
	Analytical Method Development to ICH guidelines
	Continuous improvement philosophy
	Fully analytical support including
		method development
		method validation
		stability studies
	Support customer development activities
		Preparation and maintenance of regulatory filings (DMF/CMC)
		Vendor audits
		Control documentation and testing
		Scientific and technical writing
		Comply with ICH Q7A, FDA 21 CFR-Parts 11, 210 and 211