“Our strength is in providing strategic solutions to both simple and complex product safety and development issues. Our achievement is reflected in the success of our clients.”

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Walker
Downey & Associates, Walker Downey & Associates, Walker Downey &
Associates, Walker Downey & Associates, Walker Downey & Associates,
Daniel McLain, Daniel McLain, Daniel McLain, Daniel McLain, Daniel
McLain, adverse, acute toxicity, analytical, anatomical, animal,
animals, animal model, animal studies, ASQ, audit, autism, biology,
biological, biological science, biotechnology, biopharmaceutical,
biological warfare, biodefense, biomedical, biomedical science, BLA,
carcinogenicity, carcinogen, cancer, chemistry, consumer products,
clinical, clinical testing, clinical trial, clinical chemistry,
chemistry, critical period, consulting, consultants, CFR, CTA, DART, DoD,
development, developmental, developmental toxicology, device, disease,
disease model, DNA, dosing, dose-response, dosage, drug, due diligence,
EPA, efficacy, efficacious, embryology, embryo, embryogenesis, epidemic,
environmental toxicology, expert witness, FDA, fetal, fetus, food
safety, food science, food additives, forensic, forensic science,
forensic examination, GLP, good laboratory practice, GMP, good
manufacturing practice, GXP, GCP, good clinical practice, genetic
toxicology, genetic toxicity, general toxicology, geriatrics, geriatric
toxicology, guidelines, guidance document, harmful, harmful effects,
hematology, histology, histopathology, health, healthcare, human health,
ICH, IND, immunology, immunological, immunogenicity, immunotoxicology,
investigation, in vitro, in vivo, juvenile, kinetics, liability,
mathematical, mechanisms, medicine, medical, medical device, metabolite,
molecule, model, model development, molecular biology, MHRA, MHW, NDA,
neurotoxicity, OECD, organogenesis, organ weight, pandemic, PCR, PMA,
pharmacology, pharmaceutical, pharmaceutical science, pediatric,
pediatric toxicology, protection, preclinical, preIND, product safety,
project, project management, program, program management, protocol,
protocol development, quality, quality audit, quality assurance, quality
management, regulatory, regulatory affairs, regulatory submission,
rules, RAPS, reproductive, reproductive toxicology, reproduction,
repeated dose, research, risk, risk assessment, risk management, risk
review, safety, safety pharmacology, safety evaluation, science,
standards, SOP, SOT, statistics, statistical, study, study director,
toxicology, toxicology specialist, toxicity, toxicological,
toxicokinetics, testing, test system, vaccine, vaccine development,
vaccination, 510K, veterinary, WHO, biocompatibility, biological safety,
immunochemistry, transgenic mouse, chronic toxicity, ISO 10993, AAMI,
TAG 194, safety test, biosafety, sample size, biostatistics,
statistician, biostatistician, equivalence, equivalent, substantially
equivalent, better than, claim, performance, efficacy, statistical plan,
database, data entry, double, Part 11, hypothesis, null, sponsor,
literature, investigator brochure, research, study, trial, studies,
response variable, endpoint, case report form, investigator, site,
center, technical writer, CDRH, premarket notification, IDE,
investigational device exemption, submission, approval, premarket,
quality, competitive intelligence, corporate intelligence, medical
market, market research, corporate spy, SCIP, training, seminar,
conference, onsite, education, certification, survey, IVD, in vitro
diagnostic, combination product. quality control Statistical process control
DOE Design of experiments PQ IQ OQ Qualification validation SPC QA QC RA
DMF Device master file Technology transferRun chart DMAIC Extractables
Leach Leachables NAMSA Data management Data analysis Database Tissue
Engineering Stability Stability study Modified general safety test ASQ
ISPE Grant submissions