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
A flexible approach to global regulatory affairs
In this application note, QPS describes how its global regulatory affairs (GRA) focuses on partnering with pharmaceutical, biotechnology, and medical device companies to help them to develop custom-built, efficient, and compliant research solutions.
Five criteria to use when selecting a CRO for a gene therapy study
With cell and gene therapies (CGT) quickly making their way from theory to clinical practice, many biopharmaceutical companies are looking for CRO partners with significant experience conducting CGT-focused clinical studies. In this white paper, QPS describes five criteria to consider when evaluating organizations.
Regulatory considerations in gene and cellular therapy development
In this white paper, QPS discusses how to navigate the gene and cellular therapy landscape, from preclinical and clinical study considerations to expedited programs and accelerated approvals.
