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Technical Support / QC
R&D
FDA Services
  CRO

Contract Research Organization Service

  Services Include:  
 

Compound library generation

Process development and scale up

Protein expression from cDNA clones

Protein purification

Recombinant library screening

Cell line characterization and banking

Lead discovery and optimization including GPCR screening

Custom assay development and screening

Normal tissue screening

Target validation

Tumor xenograft model

Animal efficacy evaluation

HERG assays (in vitro and in vivo)

Safety pharmacology models

Radioisotope labeling

Predictive pharmacology

Preformulation studies

Formulation

Alternative drug delivery methods

Rodent toxicology

Canine toxicology

Primate toxicology

GLP safety toxicology

Irritation studies

Inhalation studies

Pharmacokinetics

Toxicokinetics

Pharmacodynamic endpoints

Biomarker assay development, validation and clinical testing

ADME

Immunotoxicity testing

Reproductive toxicology

Genetic toxicology

Analytical methods development

ICH stability studies

Quality assurance

Regulatory support

CTM manufacturing

Pre-IND meeting

IND submission

ANDA submission

CGMP complains

Investigator's brochure

Regulatory affairs including QA/QC auditing

 
     
  Services Categories  
 

Biopharmaceutical cGMP Product Manufacturing And Development

Toxicology

Genetic Toxicology

Formulation development

Immunotoxicology

Pathology

DMPK

Analytical

Animal Disease Modeling

Safety Pharmacology
Service Categories
Early Clinical Trial Management

Regulatory Consulting