Clinical Development Support - Accelerating Drug Development Through Strategic Clinical Planning

CRO due-diligence and selection

Infrastructure assessment, regulatory track record verification, product specific past experience, QA metrics, time and cost trade-off

Study Planning & Execution

Protocol preparation & review, participant & patient recruitment, dosing & sample handling, BA Methodology suitability & validation, PK-PD statistics, report review & submission.

Regulatory readiness and risk mitigation

Gap assessment vs FDA/EMA expectations, CAPA planning, audit trails, documentation & governance KPIs to de-risk approvals and keep programs
on schedule.

Why Our Approach Wins?

Leverage our 30+ years of specialized expertise to design regulatory-optimized clinical
programs across dosage formats.

2000+ Studies

Proven frameworks refined through 2000+ early and late stage PK studies

Tier-1 Partner Network

Access and synergies with leading CROs in India and Europe for in-vivo & in-vitro PK studies

360° Regulatory Support

Active collaboration with sponsors and CROs to preempt compliance challenges

Clinical Trials: BA/BE Studies

We deliver end-to-end bioequivalence (BA/BE) studies and clinical trial solutions for complex formulations, including inhalation products, hybrid 505(b)(2) applications, and therapeutic equivalence assessments.

Phase I–IV Clinical Development

Dose optimization (e.g., ascending-dose studies for novel delivery systems), Phase III efficacy comparisons.

Global Regulatory Readiness

Tailored submissions for USFDA, EMA, and worldwide agencies, with expertise in psychiatry, diabetology, and oncology

Timeline Optimization

Streamlined pathways for complex generics and innovative therapies, prioritizing patient safety and real-world effectiveness

Need to speak to us? Feel free to drop a message

Navigation

Contact Information

Location

A 410, Shelton Sapphire, Plot no 18 & 19, Sector 15, CBD Belapur, Navi Mumbai, Maharashtra 400614