Benefit-Risk Considerations for Product Quality Assessments; Guidance for Industry; DRAFT GUIDANCE

whitePaper | March 24, 2023

The global biotech industry continues to witness growth with an estimated market size of nearly $300B, despite the current state of the funding environment

whitePaper | February 2, 2022

Vaccines work by preparing a person’s immune system to recognize and defend itself against a specific disease.

whitePaper | February 15, 2023

The discovery of both CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and associated proteins, the Cas nucleases, has revolutionized the field of gene-editing.

whitePaper | September 10, 2022

Droplet Digital PCR (ddPCR) provides highly precise and absolute quantification of nucleic acids by counting nucleic acid molecules encapsulated in discrete water-in-oil droplets.

whitePaper | November 21, 2019

Our Accounting and Finance team has published an overview of the accounting and finance challenges facing the Biopharmaceutical industry and interrelated Biotechnology organizations.

whitePaper | August 7, 2022

The number of biologic new molecular entities approved by the FDA has increased over the last five years indicates a growing focus on biosimilar.