ALEXANDRIA, Va., March 17, 2021 /PRNewswire/ — In the competitive FDA and USDA space, mergers and acquisitions of brands and companies lead to increased synergies and market share. Without careful and early due diligence assessments, however, these transactions can also increase exposure to regulatory risk. Having a clear and unbiased picture of the state of regulatory and quality compliance is a critical part of an overall due diligence assessment.
EAS Consulting Group’s due diligence services support regulatory and compliance reviews of Private Equity (PE)/Venture Capital (VC) mergers and acquisitions. Our in-depth compliance, quality and regulatory risk assessments detail any gaps and necessary corrective actions, offering a complete and unbiased picture of regulatory and quality compliance exposure to FDA enforcement, which can have far reaching and potentially negative financial implications.
Our findings are captured in a detailed report and include a summary of observations, their criticality, and recommended corrective actions that should be considered either prior to or after the transaction.
EAS Consulting Group’s audits are customizable to your needs and goals and can be conducted on short notice and may, in part, be done virtually. We review, assess, and identify issues regarding prior FDA enforcement actions, state of compliance with FDA and USDA current GMP regulations, supplier management, equipment operations and training standards, inappropriate marketing and claims statements, and compliance with appropriate FDA or USDA facility and laboratory regulations. Additionally, through our strategic alignment with Certified Laboratories, we can facilitate any product testing requirements.
EAS welcomes the opportunity to discuss your due diligence needs and how we may support you. Whether as part of a broader M&A effort or an internal review in preparation for an acquisition, EAS and Certified Laboratories offer a reliable, rapid, flexible, comprehensive, accurate and customizable portfolio of due diligence services.
Download our Due Diligence and M&A Regulatory Support Service Sheet here and learn more about our Virtual Consulting Services here. We also support Food and Drug attorneys and in-house counsel through Due Diligence Assessments and Expert Witness Services for litigation matters. Contact EAS President, Dean Cirotta for more information at 571-447-5508.
About EAS Consulting Group
EAS Consulting Group, a member of the Certified Group of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.
Through our alignment with Certified Laboratories, a leading full-service food testing laboratory servicing the food industry since 1926 (certified-laboratories.com), Labstat, a best in class tobacco, nicotine and vape safety laboratory (labstat.com) and Labs-Mart, a dietary supplement, vitamin, and healthy products laboratory, (labs-mart.com), EAS can assist you with your regulatory requirements and challenges, while offering a more robust scope of testing services to meet your organization’s sophisticated needs.
From strategic product development, toxicology and microbiology assistance, preparation of technical submissions such as GRAS, Food Additive Petitions, DMFs, NDIs, 510(k)s and more; to FSMA compliance, expert witness services, due diligence assessments, or support after receipt of a FDA form 483 or Warning Letter, including market withdrawals, recalls and improvement plans with follow-on mock-FDA inspection audits, EAS offers the detailed knowledge and experience your company requires to ensure accurate and timely assistance. With our vast expertise in FDA’s policies and enforcement, EAS is the proven choice for assistance with FDA, product testing and other regulatory solutions. easconsultinggroup.com
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