Environmental Assessment Don't let your environmental package be a regulatory sticking point. Aquality Environmental Assessment (EA) package is a critical component of animal health and many other new drug product submissions. Not having hte right data--or not starting EA investigations soon enough--is an often-underestimated development risk. In fact, these common missteps can lead to lengthy environmental fate or ecotoxicity studies that will delay a drug's approval by up to two years. Who Better to Predict Potential Environmental Effects of Your Drug than the CRO Who Helped Develop It? While rarely a focus of development strategy, evaluating a drug's potential environmental impact requires diverse and highly specialized expertise. ABC Laboratories draws on 40 years of experience analyzing the effects of chemical and biological matierals in non-target species and complex environmental matricies. We understand FDA and EMEA requirements for pharmaceutical and animal health product EA submissions, and offer the full package of GLP-compliant product chemistry, ecotoxicology and environmental fate services--including in-house synthesis of 14C-labeled materials for turnkey metabolism studies. Who Better to Predict Potential Environmental Effects of Your Drug than the CRO Who Helped Develop It? At Analytical Bio-Chemistry Laboratories, we deliver more than submission-ready, GLP-compliant EA data. We deliver the ABC Difference. That means expert guidance on study design, well-defined communication plans, and professional program management to ensure the seamless, simultaneous execution of the diverse study types an EA package often requires. We make it our business to ensure your success. The U.S. Food and Drug Administration (FDA) requires that an environmental assessment accompany any New Drug Application (NDA) or Animal NDA for a drug with an expected environmental concentration greater than one part per billion (ppb), as well as those known to cause adverse ecotoxicological effects at lower concentrations. Through established relationships with consulting firms specializing in NDA/NADA risk assessments and registration submissions, ABC will guide our customers through regulatory requirements and prepare the necessary EA summary report for submission to the FDA. Additionally, ABC conducts environmental risk assessments (ERAs) under European Union Directive 200/83/EC. ERAs are required if the Predicted Environmental Concentration (PEC) is >0.01 ppb in water or ≥10 ppb in soil, or if effects are suggested at lower concentrations based on related substances or biological studies. Environmental risk assessments are required for all new animal health drugs. Physical-Chemical Properties Water Solubility (FDA TAD 3.01 / OECD 105) n-Octanol/Water Partition (FDA TAD 3.02 / OECD 107) Vapor Pressure (FDA TAD 3.03 / OECD 104) Dissociation Constant (FDA TAD 3.04 / OECD 112) Ultraviolet-Visible Adsorption Spectrum (FDA TAD 3.05 / OECD 101) Melting Temperature (FDA TAD 3.06 / OECD 102) Density and Relative Density (FDA TAD 3.07 / OECD 109) Environmental Fate Sorption/Desorption (FDA TAD 3.08 / OECD 106) Hydrolysis (FDA TAD 3.09 / OECD 111) Photodegradation in Water (FDA TAD 3.10 / OECD Monograph 61) Aerobic Biodegradation in Water (FDA TAD 3.11 / OECD 301 and 302 Series) Aerobic Biodegradation in Soil or Sediment (FDA TAD 3.12 / OECD 307 or OECD 308) Environmental Effects Algal Toxicity (FDA TAD 4.01 / OECD 201) Microbial Growth Inhibition or Activated Sludge Respiration Inhibition (FDA TAD 4.02 / OECD 209) Seed Germination & Root Elongation (FDA TAD 4.06 / OECD 208) Seedling Growth (FDA TAD 4.07 / OECD 208) Daphnia magna Acute Toxicity (FDA TAD 4.08 / OECD 202) Daphnia magna Chronic Toxicity (FDA TAD 4.09 / OECD 211) Hyalella azteca Acute Toxicity (FDA TAD 4.09) Freshwater Fish Acute Toxicity (FDA TAD 4.11 / OECD 203) Earthworm Subacute Toxicity (FDA TAD 4.11 / OECD 203) Freshwater Fish Early Life-Stage Toxicity (OECD 210) Earthworm Reproduction Toxicity (OECD 222) Soil Arthropod Toxicity (ISO 11270) Soil Microorganisms: Nitrogen or Carbon Transformation (OECD 216 or 217)