Compliance with CMC Regulatory requirements is paramount for successful market entry. We follow guidelines from regulatory authorities such as the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), and other regional health authorities.
These guidelines cover various aspects, including manufacturing practices, quality systems, analytical methods, stability testing, and validation. Compliance involves meticulous documentation, adherence to good manufacturing practices (GMP), and implementing effective quality management systems (QMS).
Our team of experienced regulatory specialists provides CMC (chemistry, manufacturing and controls) services (w.r.t drug substance / active pharmaceutical ingredient) that seamlessly integrate drug development with regulatory submissions while ensuring compliance with the latest regulatory standards.
Acting as a liaison between organizations and regulatory agencies worldwide, our team serves as a vital link to facilitate successful communication and collaboration throughout the drug development process.
Our areas of expertise
- Regulatory strategy
- CMC sections for APIs for IMPD, IND, NDA and ANDA registrations
- Review of CMC sections prepared by customers (gap assessment, consistency)
- Response to deficiencies
- Comprehensive risk assessment reports for elemental impurities (as per ICH Q3D), potential genotoxic risk assessment (as per ICH M7), and nitrosamine risk assessments
- Tracking regulatory developments
- Ensuring regulatory compliance
