Be a Quality Control Review Advocate
By Jenny Thayer, BioBridges’ SVP Medical, Regulatory, Scientific Communications While a quality control (QC) review of a regulatory document is essential, it is often the easiest step to skip or...
Regulatory Changes in Life Sciences: 5 Key Updates
Working in life sciences is exciting because of the ever-changing landscape. In a constantly evolving industry, new regulations and legislation continuously emerge. As a life sciences professional, staying current is...
Case Study: Quality Assurance Review and Inspection Readiness
As an established pharmaceutical company focused on neurological diseases was preparing for a submission and realized that they had not fully completed the necessary quality GMP and GCP activities during the course of the program.
Case Study: Program Management & Cross-Functional Teams
A virtual company submitted their first IND and needed an effective and nimble project team to oversee their clinical program, develop clinical documents for regulatory submissions, and support overall business development.
Case Study: Strategic Cross-Functional Collaborative Leadership
A premier academic institution and research center with critical partnerships with large pharma, biotech, and device organizations recognized a gap: they required industry experience to effectively collaborate with their sponsor partners. Additionally, our client faced the emerging challenges of managing the ever-changing considerations resulting from COVID-19, which were amplified due to their lack of experience with a remote work force.