The life sciences industry is formulating the future — and reinventing itself in the process.
Investor interest, technological advancements and collaborations are driving innovation. But the path to innovation is not without challenges. As they pursue drug development, growth-stage biotechs, med device companies and large pharmaceuticals alike will face financial risk, changing regulations, supply chain disruption and uncertain ROI.
BDO’s Life Sciences consulting practice offers a full suite of tax, assurance and advisory services to help clients thrive in this evolving space. Our deep industry experience makes us a valuable catalyst for our clients’ success. Our BioProcess Technology Group (BPTG) provides pharmaceutical consulting and technical support with Chemistry, Manufacturing and Controls (CMC) across each stage of the drug development process, from pre-clinical research through commercialization. We also assist with ESG, including helping facilities become LEED certified and documenting clinical trial transparency.
In life sciences, scientific and technological advancement creates opportunity: bringing investor interest, growth potential and competitive advantage. BDO stands ready to assist with technical development, risk management, revenue optimization and accelerating speed to market.
The State of Outsourced Mammalian and Microbial Capacity
January 2, 2023
Article
The State of Outsourced Mammalian and Microbial Capacity
January 2, 2023
BDO’s bioTRAK database, which tracks supply and demand for biopharmaceutical manufacturing capacity, is showing that outsourcing in the industry isn’t going away anytime soon.
What we learned at Day 2 of BARDA’s 2022 Industry Day Conference
December 18, 2022
Article
What we learned at Day 2 of BARDA’s 2022 Industry Day Conference
December 18, 2022
For those in the Life Sciences space – check out Part Two of our series on key takeaways from the Biomedical Advanced Research and Development Authority (BARDA) Industry Day annual conference.
What we learned at BARDA’s 2022 Industry Day Conference
November 21, 2022
Article
What we learned at BARDA’s 2022 Industry Day Conference
November 21, 2022
Each year the Biomedical Advanced Research and Development Authority (BARDA) holds an annual Industry Day conference showcasing successful industry partnerships and providing insight into future federal interagency priorities to support product development to address public health threats. BARDA and their interagency partners provide nondilutive funding to support advanced research and development of medical countermeasures (MCMs).
Ask These Questions Before Pursuing an M&A Transaction
November 6, 2022
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Ask These Questions Before Pursuing an M&A Transaction
November 6, 2022
For life sciences companies, M&A and collaborations are a key strategy for growth, building product pipelines and getting products to market as quickly as possible.
Regulations in the European Union for the Use of Triton X-100 in the Pharmaceutical Industry
November 3, 2022
Article
Regulations in the European Union for the Use of Triton X-100 in the Pharmaceutical Industry
November 3, 2022
Today, most pharmaceutical companies developing new products and processes are avoiding the use of Triton X-100 and instead searching for alternative options.
BDO’s Healthcare and Life Sciences Data Protection Webinar Series
October 30, 2022
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BDO’s Healthcare and Life Sciences Data Protection Webinar Series
October 30, 2022
Join BDO’s Governance, Risk and Compliance team for a webinar series to learn more about how we help companies address their performance, regulatory compliance and governance challenges, which can impact leaders from the Board of Directors to the General Counsel and executive team.
A master file is a confidential document that covers detailed information about facilities, processes and articles used in the manufacturing, processing, packaging, and storing of biologic, drug, and device products.
Procedural Requirements for Initiating Clinical Trials in The European Union
September 19, 2022
Article
Procedural Requirements for Initiating Clinical Trials in The European Union
September 19, 2022
Prior to initiation of a first-in-human clinical trial, a sponsor must submit scientific data to demonstrate that the drug product is safe for use in humans.
This edition of BDO’s Biotech Brief examines the most recent 10-K SEC filings of companies listed on the NASDAQ Biotechnology Index, which includes organizations classified as biotechnology or pharmaceutical companies according to the Industry Classification Benchmark, that also have a market capitalization of at least $200 million.
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