Human Pharmacology Studies
Human Pharmacology Research & Studies
Syngene's Human Pharmacology Unit (HPU) has state of the art infrastructure spread over 22,500 sq. ft. with 114 beds. This unit has been audited by the US-FDA, ANVISA (Brazil) and EMA (AGES-Austria and AEMPS-Spain). It has also received approvals from the Ministries of Health of UAE and Malaysia.
Our HPU has a fully equipped 8-bed ICU and has contract with a tertiary care hospital (located within 3 KM) for handling medical emergencies. HPU uses in-house clinical lab for volunteer screening and safety evaluations, thus reducing the turn-around time. With a team of experienced research professionals trained in different aspects of early phase clinical development programs, Syngene’s HPU conducts Phase-1 and BA/BE studies with a strong commitment to quality.
The HPU has a dedicated QC team to ensure that all studies are conducted in compliance with protocol, Standard Operating Procedures (SOPs) and applicable guidelines and regulations. In addition, Syngene’s Quality Assurance team independently monitors the quality of all the deliverables. These studies are conducted in accordance with national and international Good Clinical Practice (GCP) guidelines and regulatory requirements.
Our early phase clinical development services include:
- Bioavailability/bioequivalence studies
- Pharmacokinetic/pharmacodynamic studies
- Phase I / First-in-human studies
- Drug-drug-interaction studies
- Proof-of-concept studies
Partnering with Syngene’s HPU for clinical development services offers the following advantages:
- Extensive experience in conducting phase I and BA/BE studies in healthy volunteers and special populations.
- Well established project management systems and several years of experience in working with overseas sponsors.
- Experienced team for coordinating and obtaining regulatory approvals/licenses from local regulatory agencies.
- State-of the-art infrastructure, FDA and EMA audited clinics and bio analytical labs, and CAP accredited Central Laboratory.
- Flexible pricing model by offering services on standalone basis and also as a full service suite.