Other Regulatory Consulting Services
CSI can provide support for other regulatory arenas, including:
CSI can provide adjuvant product registration at the state level. Our staff has experience in adjuvant product registration within the states that require registration. Adjuvants are currently exempted from federal registration because there is no claim for any efficacy of the adjuvant itself against any pest, they just help pesticides work better. Adjuvants are used to enhance the activity of a pesticide and include products such as a wetting agent, spreading agent, deposit builder, adhesive, emulsifying agent, deflocculating agent, water modifier, or similar agent, with or without toxic properties of its own, intended to be used with another pesticide as an aid to the application or effect of the other pesticide.
Food Contact Materials
CSI can provide advice on regulatory and scientific approaches for food packaging materials used in the US and EU. Our staff has experience in migration study placement and evaluation to meet food contact requirements of the US Food and Drug Administration and EC Regulation 1935/2004. We can place and monitor migration/toxicology tests, evaluate the data, and prepare detailed safety narratives (risk assessments). Such studies might include a bacterial mutagenicity assay (Ames Test), chromosome aberration test, assessment of mutagenicity in mammalian cells, sub-chronic rodent studies, and reproduction studies, if necessary.
CSI can obtain first-time registration approvals in all 50 States, District of Columbia, and U.S. territories. Support is also provided for annual renewal of product licenses according to individual State schedules and fees. We can develop required registration submission packages and associated materials (e.g., product labels, MSDSs, technical data summaries, etc).
GLP & QA Consulting
CSI can provide a Good Laboratory Practice (GLP) and Quality Assurance (QA) service. Click on our GLP/QA promotional service flyer for more information. This service includes on-site inspections and audits of GLP compliant facilities (and of those seeking to obtain GLP accreditation), mock regulatory inspections to identify GLP deficiencies, GLP training assistance, QA support, and on-site placement of QA professionals to provide supplementary support to in-house GLP units.
If you would like further information about CSI’s services in any of these sectors, please Contact Us.