In today’s highly regulated and technically demanding global pharmaceutical landscape, the role of Quality at Suanfarma is foundational, not only for ensuring regulatory compliance, but for fostering lasting confidence across the full product lifecycle. Quality is embedded from early-stage development through to market delivery.
We do not rely solely on systems and checklists. At Suanfarma, Quality is a proactive discipline, designed to support our partners through every key milestone of medicine development.
A Stage-by-Stage Approach to Quality:
- Clinical Development (e.g. Phases II and III) – Application of adequate GMP for Investigational Medicinal Products, and robust data documentation supports reliable study outcomes and regulatory readiness.
- Process Development & Scale-Up – Implementation of phase-appropriate GMP aligned with ICH Q8-Q10 principles ensures smooth technology transfer, scalability, and alignment with future commercial requirements.
- Commercial Manufacturing – Full adherence to GMP, GDP, and international regulatory standards ensures consistent product quality, supply chain security, and inspection readiness, supporting market access across geographies.
Global Standards, Operational Excellence
Our Quality Management System is globally aligned and locally responsive. We maintain active collaboration with leading health authorities, including the FDA and EMA. This allows us to anticipate regulatory expectations and ensure successful product positioning.
Our commitment is demonstrated by:
- Full GMP compliance across all sites
- ISO 14001 Environmental Management Certification
- Risk-based audits and real-time KPIU tracking
Regulatory Affairs: Enabling Innovation Through Compliance
The Regulatory Affairs (RA) team at Suanfarma plays a central role in connecting scientific development with regulatory authorization. By engaging early and consistently with regulatory bodies, the RA team supports development paths that are both innovative and aligned with global requirements.
RA expertise includes:
- Preparation and submission of market authorization dossiers (FDA, EMA, etc.)
- Management of regulatory variations, renewals, and compliance updates
- Strategic guidance to development teams on evolving global regulations
What This Means for Our Partners
- Products designed and manufactured with the appropriate level of quality at every stage
- Systems and documentation aligned with international regulatory expectation
- Shorter time-to-decision across development and market approval milestonesTransparent, inspection-ready operations
- Reliable support across the full product lifecycle
At Suanfarma, quality is not isolated to a function – it is part of our culture, processes, and strategic focus. By applying the right quality at the right time, we empower our partners to navigate development more efficiently, industrialize more intelligently, and bring medicines to market with confidence.
