Tag: Camargo

505(b)(2) Regulatory Planning: Designing Streamlined Programs to Create Value for Patients and Sponsors

Sponsors can use the 505(b)(2) pathway to develop drugs with new indications, dosage forms or strengths, formulations, dosing regimens, routes of administration, or even active ingredients. In many cases, these changes create new, differentiated products that patients or healthcare providers prefer over previous versions, leading to both improved experiences for patients and tremendous commercial value...

Premier Research Launches Premier Consulting Business Unit, Creating Unified Regulatory and Strategic Product Development Brand

Morrisville, N.C., February 22, 2022 — Premier Research launched Premier Consulting today by consolidating two legacy brands within its portfolio — Regulatory Professionals, Inc. (RPI) and Camargo Pharmaceutical Services. Premier Consulting is a unified strategic product development and global regulatory consulting brand positioned for market leadership in support of emerging biotech and specialty pharma companies. The new...

505(b)(2) Regulatory Planning: Designing Streamlined Programs to Create Value for Patients and Sponsors

Sponsors can use the 505(b)(2) pathway to develop drugs with new indications, dosage forms or strengths, formulations, dosing regimens, routes of administration, or even active ingredients. In many cases, these changes create new, differentiated products that patients or healthcare providers prefer over previous versions, leading to both improved experiences for patients and tremendous commercial value...