Our Services
Comprehensive CRO solutions for pharmaceutical and biotech drug development — from BA/BE to Clinical Trials and Regulatory Submissions
At Synergen Bio, we provide end-to-end clinical research services designed to meet global regulatory standards. Our expertise, infrastructure, and experienced teams ensure accuracy, quality, and compliance in every study we conduct.
Bioavailability & Bioequivalence
We conduct bioavailability & bioequivalence studies across multiple dosage forms including oral, inhalation, topical, injectables & biosimilars. Our clinical team ensures subject safety, regulatory compliance & timely study completion.
Bioanalytical
Fully GLP-compliant bioanalytical lab with advanced LC-MS/MS fleet (Sciex 6500+, 4500, 4000). Expertise in method development, validation, and high-throughput analysis for simple and complex molecules.
Clinical trials (Phase I–IV)
From early phase to post-marketing studies, we provide complete clinical trial services including feasibility, site management, monitoring, medical writing, and pharmacovigilance.
Protocol Development & Medical Writing
Our dedicated medical writers and scientific experts support sponsors with protocol development, informed consent documents, clinical study reports (CSR), investigator brochures (IB), and regulatory dossiers.
Regulatory Affairs
We offer strategic regulatory support for global markets, including BENOC & TL applications, dossier preparation, agency communication & submissions. With experience in inspections from USFDA, EMA, CDSCO & more, we help sponsors navigate approval pathways efficiently.
Project Management
Our project management team ensures smooth coordination across clinical, bioanalytical, and regulatory functions, providing clear timelines, proactive risk management, and transparent sponsor communication to deliver compliant, efficient, and timely project outcomes.
Quality Assurance
An independent QA team oversees every stage of study conduct, ensuring strict compliance with GCP and GxP standards. Through structured audits, ALCOA++ data integrity checks, we guarantee reliability, traceability & long-term compliance of study data.
Pharmacokinetics & Biostatistics
Comprehensive PK and statistical support including study design input, SAS analysis, and regulatory-ready reporting