Knowledge Base - Massachusetts Biotechnology Council - Massachusetts Biotechnology Council

Leveraging FDA Expedited Pathways to Accelerate Product Development Veristat, LLC October 2, 2019

Veristat regulatory experts weigh in on how to use FDA expedited programs to improve your chances for success and possibly shorten timelines to approval. Read More

FDA Meeting Types Explained Veristat, LLC October 2, 2019

Holding frequent meetings with the FDA - such as Type A, Type B and Type C meetings – can help reduce both developments costs and time to approval. Read More

OrthoTrophix' Intra-Patient Randomization Design Supported by Advanced Cold-Chain Packaging April 9, 2018 in Research Papers,

Discussion regarding how OrthoTrophix and Sherpa worked through the clinical supply challenges presented by a frozen drug. Read More

Understanding Oncologists: A Detailed Examination of Practice Pressures Amplity Health Inc. January 4, 2018 in White Papers,

Oncology White Paper: A Sermo/Publicis Health Partnership Read More

Inside EU FMD and the Delegated Acts A Compliance Primer December 7, 2016 in Checklists,

If you’re just beginning your EU FMD compliance journey, this guide is for you. The EU Falsified Medicines Directive is full of detail and complexity—and you’ll need to know the ins and outs of the regulation long before... Read More

Euretos Knowledge Platform White Paper February 5, 2016

Organizing the knowledge space around disease is a crucial requirement in the Read More