Quality and Compliance
At Alpine Pharma, our Quality and Compliance services are built to uphold the highest global standards across every stage of the pharmaceutical development lifecycle. Guided by a strong commitment to
current Good Manufacturing Practices (cGMP) and regulatory alignment, we ensure the consistent delivery of safe, effective, and high-
quality products.
Comprehensive Quality Systems
We establish and maintain robust quality systems in line with ICH, FDA,
EMA, and WHO guidelines, covering every facet of formulation
development, analytical testing, and manufacturing support. Our
integrated quality framework ensures regulatory adherence and operational
excellence.
Regulatory Documentation Support
We support filings such as IND, ANDA, NDA, and other global regulatory
submissions, ensuring timely and accurate compliance.
Our experienced team provides end-to-end support in the preparation,
review, and submission of high-quality regulatory documents, including:
- CTD Modules (2.3 and 3)
- Product development reports
- Stability summaries
- Method validation reports
- Technology transfer documentation
Data Integrity & Audit Readiness
We strictly follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) to ensure data integrity. All documentation is audit-ready, and we conduct regular internal audits to maintain inspection preparedness and ongoing compliance.
Vendor & Material Qualification
To safeguard product quality and regulatory conformity, we implement rigorous qualification procedures for all vendors and raw materials. Our approach ensures a reliable, traceable, and compliant supply chain.
Training & Continuous Improvement
Alpine Pharma fosters a culture of compliance, accountability, and
continuous improvement. Through regular training programs, internal
quality reviews, and cross-functional collaboration, we ensure that every
team member remains aligned with the latest regulatory expectations and
best practices.