Due Diligence & GAP Analysis

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Are essential tools for reducing the risk for potential investors in, or prospective buyers of medical device companies. Such audits normally emphasize financial performance or other key business aspects of a target company, sometimes neglecting the regulatory risks and quality managements systems risks. Medical device companies over the world operate in heavily regulated environments. The ability of a company to meet requirements and fulfill regulations is, more often than not, the determining factor in a company’s viability and profitability.

Qserve Consultancy can assist your company with the Due diligence or GAP analyses processes whether you are considering:

• Acquisition
• Substantial investment
• Joint venture
• Other commercial relationship, e.g., exclusive distribution rights, or

• Any commercial transaction which might commit your company to significant regulatory exposure.

Our certified, highly-competent Lead Auditors are your guarantee for the most effective and cost-efficient due diligence & GAP analysis process. We have many years of senior (management) experience in the medical device industry and the skill-set required to conduct a successful regulatory due diligence audit and/or GAP analysis. As required, we offer on-site services, or off-site review, where the vendor is able to provide the paperwork necessary to conduct a thorough and reliable appraisal.

We can be of assistance with the assessment of:

• Research Compliance

Preclinical and clinical research compliance is particularly important for those organizations considering the acquisition of, or investment in, medical device companies with novel technologies or applications. Questions that need to be addressed include: Identification of related areas of regulatory scrutiny and compliance, including laws regulations, policies and guidelines of applicable research jurisdictions; has the study been reviewed and accepted by the appropriate bodies? Are their any issues arising from the conduct of the study and study subject numbers, which may provide cause for concern? Are there any problems with the validity of the data collected? Have there been reports of Adverse Events, which might put the intended user at risk? If the study is on-going, will it be completed on time and will it reach the required number of study subjects? Qserve will provide your company with a thorough and accurate analysis of the target company’s (pre)clinical research activities, identifying any intrinsic or latent risks to your potential investment.

• Regulatory and Quality Management System Compliance

The scope of the regulatory compliance audit varies widely, depending on specific circumstances, but due diligence always begins by determining the nature and extent of the target company’ s medical device business and the regulatory and legal jurisdictions within which it operates. On the basis of this information, Qserve will establish check lists, and request material and documents from the target company that will most efficiently identify that company’s compliance issues and risk elements.

Areas that are typically focused on include: Device approvals, licenses and certifications as related to specific jurisdictions. Does the vendor have an appropriate Quality Management Systems  in place. The functionality of the QMS. Results of regulatory and QMS audits by outside authorities. Results of internal audits. Essential procedures and protocols. Are products and processes properly validated? If applicable, software validations. Subcontractors and suppliers, and related agreements. Training and skills. Review of complaints and adverse events; have there been any recalls or alerts, advisory notices, etc? Review of corrective and preventive actions (CAPA’s) and their effectiveness. Review of labeling and promotional materials.

The due diligence audit also encompasses distribution activities. What is the status of the target company and its devices in the world market? What is the likelihood of obtaining regulatory approval in key foreign markets? Are there any compliance issues which might hinder a proposed distribution agreement?

Through this comprehensive review Qserve’s Expert Consultants will establish the target company’s compliance history, its current relationships with the regulatory authorities, and its abilities to deal effectively with any compliance problems as they have arisen. Qserve will identify any outstanding conformity issues you may face, the (financial) consequences of remedying such problems, and your risk exposure, current and future. We can also assist you with any remedial actions that may be necessary. The need for a buyer to correct regulatory problems may lead to a downwards adjustment in purchase price. Prompt identification of these problems will help save you time and money!

If you are about to invest in a medical device company, Qserve would be pleased to discuss your requirements for due diligence and/or gap analysis. For further information or to discuss your particular needs, please Contact Us.