Leading DMPK & Early Toxicology Experts for Novel Drug Development

As a professional preclinical Contract Research Organization (CRO), Suzhou Strivita Pharma Technology Co., Ltd. specializes in full-spectrum preclinical R&D outsourcing services for global pharmaceutical enterprises, biotech startups, universities and research institutions. Centered on core demands of innovative drug development, we deliver standardized, regulation-compliant one-stop technical solutions covering DMPK profiling, bioanalysis method development and early-stage toxicology safety assessment, effectively helping our partners shorten R&D timelines and lower risks throughout the preclinical drug development pipeline.Backed by a team of seasoned pharmaceutical technical specialists, fully standardized BSL-2 laboratory platforms and abundant successfully delivered project experience, we strictly follow international regulatory guidelines including FDA, EMA and GLP requirements to generate credible, repeatable and filing-ready experimental data. Our integrated service system seamlessly connects basic pharmaceutical research to clinical trial application, serving as a reliable long-term technical partner for global new drug researchers.

Our Flexible Study Package Selections

To match diverse R&D progress and project budgets, we offer five customizable study packages for clients to choose freely:

1. In Vitro + In Vivo Combined ADME Package: Complete DMPK assessment covering both cell-level in vitro tests and animal in vivo pharmacokinetic research

2. In Vitro DMPK Only Package: Lead compound druggability screening based on cell and cell-free biological matrix assays

3. In Vivo DMPK Only Package: Systematic animal model pharmacokinetic studies to obtain real in vivo ADME profiles

4. Independent Toxicology Studies Package: Full set of early drug safety evaluation programs

5. Full Integrated Turnkey Package: All-in-one solution combining DMPK testing, toxicology assessment and MTD preliminary trials

Core Technical Service Modules

1. In Vitro DMPK Assays (Early Druggability Screening)

In vitro ADME evaluation is the first critical filter for candidate compounds, which judges the drug-likeness of lead molecules via subcellular and cellular in vitro models, laying the foundation for subsequent in vivo trials. Our testing scope includes metabolic stability testing in liver microsomes, S9 fractions and primary hepatocytes, plasma protein binding (PPB) measurement, CYP450 enzyme inhibition and induction screening for drug-drug interaction prediction, Caco-2/MDCK cell monolayer permeability detection for oral absorption capacity evaluation, key drug transporter functional assays (P-gp, BCRP, OATPs), metabolite identification (Met ID), as well as physicochemical parameter profiling such as solubility, LogD lipophilic coefficient and pKa dissociation constant.

2. In Vivo Pharmacokinetic (PK) Studies

On the basis of qualified in vitro DMPK data, we conduct systematic animal in vivo PK experiments to acquire authentic in vivo absorption, distribution, metabolism and excretion characteristics of test drugs. Our services contain single-dose PK research with intravenous injection and intragastric administration dual routes, oral bioavailability calculation, multiple-dose repeated administration PK combined with whole-organ tissue distribution analysis, excretion balance studies in urine, feces and bile, in vivo drug-drug interaction verification, and blood-brain barrier penetration assessment via brain/plasma drug concentration ratio detection, providing solid empirical evidence for preclinical research and IND declaration.

3. Bioanalysis for Small Molecules & Large Molecules

Quantitative bioanalysis is the core supporting platform for all DMPK and toxicology projects. For small-molecule drugs, we develop and validate LC-MS/MS quantitative testing methods compliant with international standards, realizing accurate quantification of target compounds in plasma, tissues and excreta, alongside batch sample testing and standardized data collation for PK trials. For large-molecule biologics including proteins, peptides and monoclonal antibodies, we establish validated Ligand Binding Assay (LBA) systems to undertake in vivo plasma concentration quantification and anti-drug antibody (ADA) screening, finishing full-process biological sample testing for macromolecule preclinical PK studies.

4. Early-Stage Toxicology & Safety Assessment

Our toxicology service focuses on early safety risk warning of drug candidates, defining safe dose ranges and toxic target organs to supply pivotal safety data for clinical trial approval. The testing portfolio covers Maximum Tolerated Dose (MTD) pre-test, single-dose acute toxicity observation, 28-day repeated-dose cumulative toxicity study, genotoxicity detection via Ames test and micronucleus assay, safety pharmacology evaluation on central nervous, cardiovascular and respiratory systems, together with clinical pathology and histopathological examination, comprehensively guaranteeing the safety profile of investigational new drugs.

Contact Information

Company Name: Suzhou Strivita Pharma Technology Co., Ltd. Address: 1/F, Bldg 15, CECEP (Suzhou) Env Tech Park, 18 Dongchang Rd, Suzhou Industrial Park, Jiangsu, China Contact Person: Yuan Zhan | Founder, General Manager & Chief Scientist Mobile: +86 132 9116 6611 Email: zhanyuan@strivita-biotech.com Official Website: www.strivita-biotech.com