Pharmaceutical Regulatory Assistance

Document Preparation, Filing and Managing FDA Drug Applications

Filing and Managing all of the Processes for FDA Drug Applications
Submission Planning and Preparation
Pharmaceutical Regulation Consulting
Inception to FDA Qualification Filing
Accurate Regulatory Submissions
Submission Planning and Preparation
Effective procedures to comply with requirements for adverse drug event (ADE) management and reporting
Consulting for product labeling, advertising, and promotional materials for regulatory compliance
Technical writing and specifications for protocols, reports, policies, and procedures
PTS Global Consultants has assisted US, Canadian, European Union and Asian clients in reviewing and preparing key documents for review by FDA