Audit & Assurance

One of the most highly regulated industries in the United States, life sciences organizations face a myriad of challenges. From the regulatory requirements of research and product development through initial product commercialization to long after it’s on store shelves, companies have to overcome complex hurdles, ranging from managing the rigorous CMC requirements to meeting commercial contracting requirements.
 
Many businesses in the life sciences sector are also considering M&Araising capitalgoing public, or collaboration arrangements to support their portfolios of existing products. Others are looking to expand overseas into new markets, optimize their operations, understand and improve revenue management, and ensure they’re getting the full benefit from R&D tax credits. Most of these transactions are complex, multi-faceted, and create significant uncertainty regarding regulatory and financial reporting. Businesses dealing with these issues require advisors with experience and insight into these arrangements and the many challenges that come with them.
 
BDO’s Life Sciences Practice provides guidance to pharmaceutical, biotech, and medical device manufacturers at every stage of a company’s lifecycle, with services in the following areas:

  • Research and development tax credits
  • Raising capital
  • Going public
  • Valuation and business analytics
  • BioProcess Technology Group
  • Contracting Solutions
  • Government Pricing Strategy and Compliance
  • Finance
  • Biodefense


 
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