Regulatory affairs support provided by RAC certified professionals.
Experienced and effective PM support catered to the needs of the project and company.
Partner services to support CMC & BLA dossier writing and project management activities for biologics and drug submissions.
Develop precise and effective documentation services.
Compilation and Data Analysis of Clinical Data along with QC/QA checks, compliant to GCP standards.
Research project expertise in neurology, autoimmunity, auto-inflammatory, and immune-oncology disease areas.
Experienced and effective PM support catered to the needs of the project and company.
Research project expertise in neurology, autoimmunity, auto-inflammatory, and immune-oncology disease areas.
Regulatory affairs support provided by RAC certified professionals.
Compilation and Data Analysis of Clinical Data along with QC/QA checks, compliant to GCP standards.
Partner services to support CMC & BLA dossier writing and project management activities for biologics and drug submissions.
Develop precise and effective documentation services.
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
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