Regulatory Affairs
Propel Regulatory Affairs and Quality Assurance team provides global regulatory and auditing services to the pharmaceutical and biotech industry. We understand the need to maintain 100% compliance with industry regulation and guidelines.Our Regulatory Affairs and Quality Assurance services include:
- Regulatory Strategy
- Formulation and Review of Product Applications
- Briefing Document Preparation
- Label Development and Review
- Investigative Site Audits
GMP/GLP/GCP AuditsDue to the criticality of balancing regulatory needs with internal efficiencies, organizations are taking a more comprehensive view of compliance. Our Validation and Regulatory Compliance consulting practice provides services in quality systems and compliance, and can assist your organization with a range of needs including compliance with regulations such as 21 CFR Part 11.Our Compliance services include:
- Clinical Study Compliance
- 21 CFR Part 11
- HIPAA
- Sarbanes-Oxley
- Compliance and Quality Systems
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Propel Solutions provides customized consulting and support services to the clients across the globe. Our highly experienced team enables us to provide 24/7 support services to the clients. Our consulting and support services are 100% focused and secured.