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Strategically managed validation and regulatory compliance consulting company serving North America from a major population center location. Services include managing and staffing projects for the validation of production facilities, utility systems, software and IT / computer systems, process control systems, manufacturing processes, and equipment systems. Regulatory Compliance services includes providing project management and staffing services for Quality System (QS) audits, validation assessments, Corrective and Preventive Action (CAPA) / Quality Investigations support, validation programs, and risk management programs. Clients requiring these services are often facing regulatory enforcement actions and have received warning letters from regulators. The firm also provides professional technical staffing solutions and services to support the contingent worker staffing needs for their clients' critical-to-business functions (i.e., quality assurance, quality control, validation, engineering, production supervision, regulatory affairs, etc.).
The company has a customer base that includes some of the world’s best-known names in the pharmaceutical and medical device industries. The company provides a wide-range of services, with broad direct product-type experience.
The company has a strong, well-established reputation for its technical expertise and capabilities. They have well-developed systems for talent acquisition and business development positioning the business for continued growth. This business has a strong culture of strategic planning, business process improvement and client-focused project execution. The owner has transitioned most sales relationships and day-to-day operations to his management team and has been actively working himself out of the business since mid-2017.
The firm is strategically developed for growth platform and has put in place industry leading branding and business development processes. Because capacity for new business is dependent on available consulting hours, the firm has developed effective talent acquisition processes that will provide the needed personnel for continued above industry growth rates. Additionally the company is beginning to introduce new service offerings.
Management feels the pharmaceutical and medical device industries are stable, and have potential to grow with business returning from off-shore to North America. The company’s customers are well satisfied with the firm’s value proposition, future business is relationship driven and there is significant repeat customer business. The significant share of the customer relationships are with employees that will remain with the business after the sale.
Owner has taken the business as far as he desires given his age and current priorities.
Reasonable support for up to six months. Owner is currently part-time and has carefully planned ownership exit. A strong leadership team, relationships and processes are currently in place for continued operation without owner presence.
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