DataRevive
ELIQUENT Life Sciences, part of the Validant Group, is a comprehensive regulatory consultancy that supports pharmaceutical, biotech, medical device, and combination product companies throughout their product lifecycle. The company offers expert guidance in regulatory strategy, CMC, preclinical, clinical, and post-approval support, with a team of former FDA professionals and industry experts. ELIQUENT aims to bridge regulatory challenges from thought to finish, enabling clients to navigate complex regulatory landscapes efficiently and effectively.
Industries
Nr. of Employees
small (1-50)
DataRevive
Rockville, Maryland, United States, North America
Services
High-level regulatory pathway selection, expedited pathway guidance, and planning across CMC, nonclinical, and clinical development phases.
Hands-on execution including dossier writing, assembly, eCTD submission, and representation at agency meetings to support IND, NDA, BLA, and ANDA filings.
Post-marketing regulatory support including GMP mock inspections, quality management system assessments, change management, and remediation of enforcement actions.
Development of CMC strategies, process development oversight, DMF writing, process validation review, and coordination with manufacturing partners.
Design and review of GLP toxicology, GLP PK, and non-GLP PD studies, protocol/report review, and PK/PD modeling to support regulatory submissions.
Clinical protocol development, study execution support, monitoring, safety reporting, and preparation of integrated safety and efficacy summaries for submissions.
High-level regulatory pathway selection, expedited pathway guidance, and planning across CMC, nonclinical, and clinical development phases.
Hands-on execution including dossier writing, assembly, eCTD submission, and representation at agency meetings to support IND, NDA, BLA, and ANDA filings.
Post-marketing regulatory support including GMP mock inspections, quality management system assessments, change management, and remediation of enforcement actions.
Development of CMC strategies, process development oversight, DMF writing, process validation review, and coordination with manufacturing partners.
Design and review of GLP toxicology, GLP PK, and non-GLP PD studies, protocol/report review, and PK/PD modeling to support regulatory submissions.
Clinical protocol development, study execution support, monitoring, safety reporting, and preparation of integrated safety and efficacy summaries for submissions.
Expertise Areas
- Regulatory strategy and submissions (IND/NDA/BLA/ANDA)
- CMC and manufacturing strategy
- Nonclinical development and toxicology
- Clinical trial design and clinical operations
Key Technologies
- eCTD electronic dossier submission
- GLP toxicology studies
- GMP inspection and mock inspection methodologies
- GCP inspection readiness
News & Updates
Guidance on resuming business operations post-pandemic.
Insights on enforcement actions and communication strategies.
In one year, DataRevive completed 5 GMP pre-approval inspections for small molecule & biological products.
Guidance on resuming business operations post-pandemic.
Insights on enforcement actions and communication strategies.
In one year, DataRevive completed 5 GMP pre-approval inspections for small molecule & biological products.