Safis Solutions, LLC Company Profile

Safis Solutions, LLC

342 Massachusetts Avenue
Suite 402
Indianapolis, IN 46204

Phone: (317) 777-6200
Fax: (317) 777-6199

CORPORATE MISSION

Safis Solutions is committed to assisting the life sciences industry in meeting regulatory and quality standards expected by global health authorities. We provide effective solutions to expedite the regulatory process and enable patients to access therapeutic and diagnostic products that improve quality of life.

KEY PERSONNEL

Diana Caldwell
Director of Sales & Marketing
(317) 777-6187
dcaldwell@safis-solutions.com

Ping Poulsen
President and CEO
(317) 777-6200
ppoulsen@safis-solutions.com

COMPANY HIGHLIGHTS

Safis Solutions, LLC is a regulatory compliance consulting company serving pharmaceutical, medical device and biotech companies worldwide to ensure health authority requirements are met. Areas of expertise include regulatory approval, clinical strategies, quality systems, validation, auditing, and post-market surveillance programs.

REGULATORY APPROVAL SERVICES

Pharmaceutical Product Approval

Medical Device and Diagnostic Product Approval

Biologics Approval

Orphan Product Approval

Food and Cosmetic Product Approval

Veterinary Product Approval

International Market Approval

CLINICAL TRIAL REGULATORY SERVICES

Preclinical and Phase I, II, III studies

Site Monitoring

Audit readiness

QUALITY COMPLIANCE SERVICES

Risk Management

Quality Program Development

Compliance Monitoring

21 CFR Parts 210 and 211 (Pharmaceuticals)
21 CFR Part 820 (Medical Devices)
21 CFR Part 110 (Food)
21 CFR Part 11 (Electronic Records and Electronic Signatures)

FDA Citations and Warning Letters

IT SERVICES/VALIDATION SERVICES

Full lifecycle software and database development

Computer system and software validation

Independent testing and verification

Instrument and machine qualification

Process qualification

Building Commissioning

AUDIT & REMEDIATION SERVICES

Pre-Audit Preparation

Vendor Auditing

Due Diligence Audit