Services

How Can SciReg Help with Your Scientific and Regulatory Challenges?

SciReg’s professionals bring a wealth of knowledge and expertise to your projects. We offer high-quality and cost-effective advice and guidance, helping our clients to choose the best strategies and then assisting with their implementation to meet client business objectives. Our staff can assist with day-to-day decisions and long-term strategic planning. We have a proven record of overcoming seemingly insurmountable obstacles.

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.
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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.
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