Click Tiles To Learn More
er experience includes pre-IND and IND package submissions for rare diseases, immunoncology, neuroscience products, BLA/ sBLA for a blockbuster GI drug, and numerous line indication submissions.
As a consultant for the GRA Department of a large biopharmaceutical company, she currently leads a team of regulatory managers. Along with managing marketing authorization submissions, Shai ensures the product's global success by maintaining active marketing authorizations and timely CMC and labeling compliance submissions in over 85 markets.
A successful regulatory submission is paramount to meeting patients' need for innovative therapies. At Antero Pharma Consulting, we pride ourselves on providing expert, bespoke services to fit your needs and bring you a step closer to that goal.
At Antero Pharma Consulting, we partner with experts in CMC, medical writing, and regulatory strategy and design projects that are not only expertly crafted but also aim to significantly reduce submission timelines, cutting them by
This efficiency is a testament to our commitment to your success.
A successful regulatory submission is paramount to meeting patients' need for innovative therapies. At Antero Pharma Consulting, we pride ourselves on providing expert, bespoke services to fit your needs and bring you a step closer to that goal.
At Antero Pharma Consulting, we partner with experts in CMC, medical writing, and regulatory strategy and design projects that are not only expertly crafted but also aim to significantly reduce submission timelines, cutting them by
This efficiency is a testament to our commitment to your success.
Optimize Draft and Review Timeline
Finalize & Establish Rolling Publishing Workflow
Full Process Breakdown
Full Process Breakdown
Position Your Biotech Asset for Success Using The Project Management Toolkit ...more
Main
September 05, 2024•2 min read
SAFETY REPORTING THROUGH PSUR/PBRER ...more
Main
September 05, 2024•2 min read
Major USFDA Regulatory Updates in December 2022 ...more
Industry Updates
September 05, 2024•2 min read
Expanded Access Program - overview and notes ...more
Main
September 05, 2024•2 min read
Major USFDA Regulatory Updates in April 2023 ...more
Industry Updates
September 05, 2024•2 min read
Position Your Biotech Asset for Success Using The Project Management Toolkit ...more
Main
September 05, 2024•2 min read
SAFETY REPORTING THROUGH PSUR/PBRER ...more
Main
September 05, 2024•2 min read
Major USFDA Regulatory Updates in December 2022 ...more
Industry Updates
September 05, 2024•2 min read
Expanded Access Program - overview and notes ...more
Main
September 05, 2024•2 min read
Major USFDA Regulatory Updates in April 2023 ...more
Industry Updates
September 05, 2024•2 min read