Regulatory Framework Experience

RegAscent has active experience working within the following regulatory frameworks:

• FDA: IND, NDA, ANDA, 505(b)(2), ODD, BLA, labeling, REMS, drug safety, biosimilars

• Health Canada: CTA, NDS, ANDS, NHP submissions, CFIA compliance, labeling

• EMA: CTD/eCTD, EU PIPs, Centralized and Decentralized procedures

• CDSCO: Drug and device regulatory submissions

• MHRA: Post-Brexit UK regulatory pathway support

• TGA: Australian regulatory documentation support

• GCC Authorities: Gulf region regulatory compliance and labeling

Product category experience:

Pharmaceuticals · Biologics · Biosimilars · Medical Devices (MDR/IVDR) · Natural Health Products · Cosmetics · Combination Products · Vaccines