QUALITY SYSTEMS

Audits and Inspections 

Implementation and Migration

Predictive Quality Systems

Quality Training 

MANUFACTURING & ENGINEERING

Process Validation

Cleaning and Sterilization Validation

Good Manufacturing Practices (GMP) Product Lifecycle Methods

Data Integrity

Computer System Validation

Equipment and Facility Engineering

REGULATORY AFFAIRS

Regulatory Submissions, Technical Writing & Regulatory Strategy Development

PMAs, 510(k)s, NDAs, ANDAs, BLAs, INDs, IDEs & other regulatory filings

International Regulatory Filings, Product Registrations & Labeling

CLINICAL

Medical Writing

Medical Monitoring

Clinical Trial Management Clinical Development / Clinical Study Design

GCP Auditing Drug Safety / Pharmacovigilance

Biostatisticians, Toxicologist & Clinical Scientists