Contract research from efficacy and toxicity to clinical trials and regulatory submission. One team owns every study from design to the final report, for human health products and for animal drugs and diagnostics alike.
Natural products, dietary-supplement and functional-food ingredients and drug candidates, taken from cell and animal efficacy through GLP toxicity to human intervention trials.
Veterinary drugs and diagnostic kits, taken from efficacy and target animal safety through field trials and kit validation to registration.
We take natural products, dietary-supplement and functional-food ingredients and drug candidates through the full efficacy-evidence path. One team owns everything from study design to a submission-ready final report for regulators worldwide.
Efficacy and mechanism in cell and disease animal models, including marker-compound selection and dose-response.
Safety packages for dietary-ingredient notification, novel-food or health-claim approval, or IND, run with OECD GLP-compliant partners. We own the design and the interpretation.
Randomized, double-blind, placebo-controlled trials that prove functional claims, run to ICH GCP with university-hospital investigators.
Prices in USD, excluding taxes. They vary with test article, species and group size, subject numbers and endpoints; formal quotes follow a consultation. Drug clinical trials (Phase 1 and beyond) are quoted separately.
Endpoints and sample size per ICH E9 and target-agency guidance
4–6 wkEthics review and ClinicalTrials.gov or national registry
4–8 wkElectronic CRF build and data-validation plan
3–4 wkRecruitment, randomization, intake, visits, GCP monitoring
4–8 moAnalysis to the SAP and a submission-ready final report
2–3 moIngredient notification, health-claim or approval dossier and agency responses
Agency reviewWe take veterinary drug candidates and animal diagnostic kits through efficacy, target animal safety, field trials and kit validation, then write the dossier for FDA, USDA, EMA and other agencies worldwide. One team owns everything from study design to approval.
Investigational file (INAD), technical sections and NADA or conditional approval.
Vaccines and disease diagnostic kits: product license or import permit.
EU marketing authorisation and national registrations in Asia and other regions.
Efficacy and mechanism in target-species cells and disease models, with pilot pharmacokinetics to select the dose for pivotal studies.
Safety packages for an investigational file or approval, run with GLP-certified partners. The target animal safety study is the core safety evidence for a veterinary drug.
Randomized, masked, controlled studies in client-owned animals that prove effectiveness under real-world use, run to VICH GL9 with veterinary-clinic investigators.
The evidence an animal-disease diagnostic kit needs for licensing: analytical performance, diagnostic sensitivity and specificity against a reference method, and lot-to-lot consistency.
Pathway strategy, dossier authoring and agency communication for animal drugs, biologics and diagnostic kits in the US, EU and other markets.
Prices in USD, excluding taxes. They vary with test article, species, group size, number of animals and sites, and endpoints; formal quotes follow a consultation. GLP facility, laboratory, investigator and animal costs and government fees are quoted separately.
Agency decision, gap analysis, study roadmap and budget
2–4 wkInvestigational file and agency agreement on pivotal protocols
2–4 moDose determination and GLP target animal safety
9–15 moMulti-site, masked, controlled study in client-owned animals
12–24 moPhased submission of effectiveness, safety, CMC and environmental sections
≈6 mo eachLabeling, FOI summary, final application and agency responses
≈2 mo reviewThe same disciplines run through both pillars: studies designed around what regulators will ask, certified partner facilities, and one team that interprets the data and writes the report.
Endpoints, sample sizes and formats chosen for FDA, USDA, EFSA, EMA or other agency review from day one.
The people who design your studies also interpret the data and write the submission.
Mechanism and efficacy know-how from one pillar strengthens study design in the other.
Transparent ranges and fixed-scope proposals, so you know each stage's cost before it begins.
Epigenix Innovation Global Co., Ltd. is a contract research organization built on genetics and epigenomics, serving two fields: human health products and animal health products.
Our work spans cell and animal efficacy, GLP safety, human and target-animal clinical studies, diagnostic kit validation, and the regulatory dossiers that turn research into approved products.
“To pioneer innovative solutions that enhance the health and well-being of people and their animal companions — setting new benchmarks in evidence-based healthcare.”Work with us
Share your product, target (human or animal species) and current stage. We will reply with the studies required, an indicative budget and a timeline.
Human health CRO · Animal health CRO & registration