Pesticides, Biopesticides, Plant Growth Regulators, Fertilizers, Bio-Stimulants, and Inert Ingredients
SciReg’s staff has broad experience in the regulation and registration of every class of pesticide product (conventional pesticides, biopesticides, and antimicrobials), plant growth regulators, fertilizers, bio-stimulants, and inert ingredients. Our professionals can provide expert guidance in all aspects of product research, development, production, registration, and defense.
SciReg’s consulting services include, but are not limited to:
Product Registration, Tolerance Petitions, and Tolerance Exemption Petitions
- Develop and implement strategies to expedite regulatory processes and to dismiss (waive) inappropriate regulatory requirements.
- Determine data necessary to support product registrations and tolerances/exemptions.
- Develop strategies to bridge data across different, but related, chemicals and/or uses.
- Meet with key government regulatory personnel to negotiate approval/registration requirements; work as advocate for client while seeking consensus with authorities.
- Identify, obtain, and summarize public domain literature that can be submitted and/or cited to support regulatory requirements.
- Prepare and present regulatory training seminars.
- Perform thorough evaluations of client internal procedures (including regulatory compliance and study design, placement, monitoring, and reporting procedures); make recommendations for enhancing regulatory compliance and for streamlining the procedures to expedite submission and approval of product applications.
- Prepare, maintain, and distribute Material Safety Data Sheets.
- Prepare and submit registration applications, tolerance/exemption petitions, Notices of Filing, product labels, offers-to-pay, data matrices, etc.
Study Design, Placement, and Monitoring
- Design, contract, and monitor product chemistry, residue chemistry, environmental fate, ecotoxicity, efficacy, worker exposure, target animal safety, mutagenicity, and mammalian toxicity studies; review draft reports and raw data to ensure supportable study interpretation prior to report finalization.
Data Compensation and Legal Assistance
- Provide scientific and study cost support for data compensation negotiations and arbitrations.
- Serve as expert witnesses for data compensation arbitrations and other legal matters involving the regulation of products.
Product Discovery, Development, and Marketing
- Identify and develop discovery, evaluation, and registration strategies that integrate with business development goals.
- Design field trial protocols and perform data analyses to ensure accurate product evaluation and understanding during product development stages.
- Provide technical support to sales and marketing groups to achieve key financial objectives.
- Design labeling that enables proper use and application of products to achieve full product potential.
- Provide input into distribution strategies to supply products to customers in a timely and effective manner.
- Obtain Plant Protection and Quarantine (PPQ) permits from USDA APHIS for importation of microbial products.
Contract Quality Assurance
SciReg’s staff includes multiple individuals certified as Registered Quality Assurance Professionals in Good Laboratory Practices (RQAP-GLP), and who are experienced with U.S. and international regulations and guidelines.
We are available to serve as a sole, third-party Quality Assurance Unit, or as a QA resource on a project-by-project basis. Services our QA team can perform include, but are not limited to:
- Perform quality assurance inspections (GLP/non-GLP) of study protocols, reports, raw data, and laboratory/field operations.
- Identify compliance issues; recommend and help implement corrective actions.
- Perform facility audits; help identify areas for process improvements.
- Prepare and present Good Laboratory Practice training programs, including mock-inspections.
- Evaluate scientific data for compliance with U.S. and international guidelines and regulations.
- Prepare, review, maintain, and distribute Standard Operating Procedures.