Pharmaceutical Regulatory Assistance

• 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