Product Safety & Regulatory Support

Veterinary Drugs

ENVIRON offers clients experience and expertise in a variety of areas related to veterinary drug products: pharmacology, toxicology, drug metabolism, molecular biology, biochemistry, analytical chemistry, environmental chemistry, and ecotoxicology. Our scientists have participated in all phases of registration of animal drug products, including preclinical study design, placement and monitoring; target animal efficacy and safety assessments; and preparation of study summaries for regulatory submissions. They have prepared specialized support documents for registrations, especially in areas related to secondary mechanisms of carcinogenesis.

Our professionals have long-standing records of success with prevailing regulatory authorities and in-depth experience and understanding of their procedural requirements. We have represented clients on matters ranging from regulatory compliance to safety evaluations.

Clients rely on us to:

• prepare expert reports presenting safety/residues and pre-clinical/clinical documentation.
• prepare summaries of both safety and residue and efficacy documentation.
• conduct Phase I and Phase II environmental risk assessment.
• support establishment of MRLs.
• liaise with regulatory authorities and interest groups.