SciReg's professionals bring a wealth of knowledge and expertise to bear on client issues and concerns. We have over 90 years of combined experience working for, and within, academia, government, and industry. We offer advice and guidance to our clients, helping them to choose the best strategies and then assisting with their implementation to meet client business objectives. Our solutions create business value for our clients. SciReg offers a full range of consulting services in the areas of:

• Registration Support and Study Conduct

• Quality Assurance

• Data Compensation and Legal Assistance

• Product Discovery, Development, and Market Assessment

• Develop and implement strategies to expedite regulatory processes and to dismiss (waive) inappropriate regulatory requirements.

• Meet with key government regulatory personnel to negotiate approval/registration requirements; work as advocate for client while seeking consensus with authorities.

• Determine data necessary to support product approvals/registrations.

• Design, contract, and monitor product chemistry, residue chemistry, environmental fate, ecotoxicity, efficacy, worker exposure, target animal safety, mutagenicity, and mammalian toxicity studies; ensure supportable study interpretation prior to report finalization.

• Develop strategies to bridge data across different, but related, chemicals and/or uses.

• 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.

• Three of SciReg’s technical staff are Registered Quality Assurance Professionals - GLP.

• Serve as sole, third-party Quality Assurance Unit, or as a QA resource on a project-by-project basis.

• 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; defend client compliance practices with regulatory agencies.

• Prepare and present training programs in the Veterinary Good Clinical Practices and the Good Laboratory Practice regulations.

• Evaluate scientific data for compliance with U.S. and international guidelines and regulations.

• Prepare, maintain, and distribute Standard Operating Procedures.

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 Market Assessment

• Identify and develop product discovery, evaluation, and registration strategies that integrate with business growth goals.

• Define patent approaches through data review in concert with business and marketing plans.

• 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 staffs to achieve key financial objectives.

• Conduct market research and analysis in support of market development to ensure maximum product sales potential.

• Design labeling that enables proper use and application of products to achieve full product potential.

• Provide input into distribution strategies which capitalize on existing strengths within systems to supply products to customers in a timely and effective manner.

Whether small or large, all companies face a range of complex issues and requirements when dealing with regulatory agencies. Many seek our professional consulting services to gain insight into how best to deal with these concerns. SciReg helps clients to establish superior relationships with regulatory agencies and to improve existing relationships. Our aim is to maintain industry leadership in quality consulting services.

Please contact us for more information regarding our services.