GMP
Dasha Pharma has collaborations with Proven GMP-compliant facilities which offer peace of mind to our customers in addition to these benefits:
- Ensured regulatory compliance from development, analytical services, and cGMP manufacturing to later stage development and commercialization with full CMC and RA support.
- Accelerated process development and scale-up under increased GMP requirements.
- Enhanced regulatory audit readiness (pre-approval inspection or GMP re-inspection), including virtual audit capabilities
Track record of successful audits. - Established registered starting material (RSM) assessment and regulatory concept.
- Adherence to commercialization production timeline.
