QPS Global Regulatory Affairs Services
QPS Global Custom-Built Regulatory Services Can Transform Clinical Trials. QPS Global Regulatory Affairs (GRA) service offerings focus on helping pharmaceutical, biotechnology, and medical device companies to develop custom-built research solutions that forge expedited regulatory pathways from discovery to global commercialization and onwards through product lifecycle support.
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QPS Global Custom-Built Regulatory Services Can Transform Clinical Trials.
QPS Global Regulatory Affairs (GRA) service offerings focus on helping pharmaceutical, biotechnology, and medical device companies to develop custom-built research solutions that forge expedited regulatory pathways from discovery to global commercialization and onwards through product lifecycle support.
- Preclinical: Strategic Regulatory Planning, INTERACT, Pre-IND/CTA Meeting, Accelerated Programs, Regulatory Briefing Documents, Regulatory Communications, and FIH Regulatory Submissions
- Early Phase Clinical: Rolling Submissions, Accelerated Programs, Annual Reports, Supplements, Safety Reporting, Regulatory Briefing Documents, and Regulatory Communications
- Late Phase Clinical: Annual Reports, Supplements, Safety Reporting, Regulatory Briefing Documents, Regulatory Communications, Commercial Regulatory Filings and Inspectional Readiness
- Post Approval Activities: Post-Approval Commitments, Annual Reports, Supplements, Safety Reporting, Pharmacovigilance, Inspection Findings, Commitments and Responses
