PRIVATE EQUITY FIRMS & CORPORATE FUNDS
For investors that that specialize in the Food (and Medical Foods), Animal Feed, Dietary Supplement, Cosmetic or Homeopathic industries, we have highly experienced regulatory and scientific professionals on staff to support the evaluation and due diligence for product and operational compliance. Evaluating sales or financials is not enough to ensure a deal is solid and that no regulatory risks will undermine your investment or acquisition. We have one of the most thorough auditing, reporting and regulatory risk analysis practices that will help ensure a solid agreement is made.
We provide investors, private equity firms, and corporate funds with regulatory guidance on investment opportunities, acquisitions, in-licensing and related due diligence to ensure that the given products, operations and strategy are compliant. Our phased and risk-based approach helps to quickly uncover areas that require remediation or that simply re-affirm the overall investment strategy is sound for your new management team and more importantly your investors.
REJIMUS provides the evaluation of ingredient and/or finished products in the above markets to ensure the overall strategy is allowed and what, if any, risks are to be aware of. Additional, if there are parameters to identify or have addressed, a regulatory gap analysis or feasibility study can promptly help your team make critical “go, no go” decisions.
• Evaluating Content, Use and Structure/Function Claims
• Ingredient Regulatory Status
• Regulatory Guidances & Interpretation
• Agency Actions Summary
• Operational Compliance
• Supply Chain Auditing and Qualification
• QA and QC Budgeting
• Expert Professional Opinion and Technical Insight’s
REJIMUS helps investors and investment firms better qualify companies by ensuring operational compliance with the applicable regulation depending on the type of operations, products, ingredient and target market. Our team has expertise in all areas of labeling, manufacturing and production, analytical testing, GMP facility auditing, supply chain qualification, and technical marketing for the markets served.
We provide consulting for Litigations stemming from Quality and/or Regulatory Non-Compliance events, FTC actions, FDA Inspections, Form 483’s and Warning Letter responses as well as GMP compliance planning. Turn-around strategy development and implementation, inclusive of budgeting and management guidance for the restructuring of quality and regulatory operations are routine.
Areas of support include:
• Dietary Supplement Consulting
• Facility Audits (in the US and internationally)
• Product Development and Analytical Testing Strategy Support
• Quality Program Optimization and Gap Analysis
• Compliance Operations Planning & Implementation
• Quality Agreement for Laboratories, Manufacturers and Distributors