Strategic advice for pharma and biotech

Due diligence and gap analysis

Support with due diligence and gap analysis is a vital part of any forward-planning activity and can help your company to become aware of and avoid regulatory pitfalls. You will have any organisation’s strengths, upsides, weaknesses, or shortcomings mapped in good time before a possible merger or acquisition, or an inspection.

By performing due diligence and gap analysis with support from Arex Advisor, you can gain highly valuable information, and loser the risk for your investment or business.

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Pharma due diligence essentials

Due diligence in the pharmaceutical industry is done in order to check for compliance, as well as to investigate the potential of an investment. It can take place when a company is embarking on a merger or acquisition, or when buying an asset or a product from another company.

Experienced specialists who know what warning signs to look for in a due diligence check, but smaller companies specially may lack this specific expertise.

A gap analysis compares your product of interest against an identified regulatory requirement and finds the gaps in compliance that you should close.

A gap analysis is a very important step in any compliance project or program, but it is only part of the journey towards compliance. We believe that investment in planning will result in a far better prospect of identifying gaps accurately and pinpointing the most efficient and cost-effective measures for your organization to close the gap.

Why use our support with due diligence and gap analysis?

Arex Advisor have experience in:

-Handling due diligence working streams within regulatory affairs, quality assurance and pharmacovigilance
-Providing systematic review of a project or a product portfolio in a M&A to evaluate and assess the regulatory status
-Identifying and organising the regulatory, technical, and clinical documentation to de-risk the business transaction
-Assessing and analyzing gaps not only in due diligence, but in other regulatory processes as well.

This will provide important information not only on what the gaps are but on ways to mitigate and avoid them.

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Regulatory strategies and plans

Your contact person
Portrait of Erik Hedner Arex Advisor

Erik Hedner

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.