Delivering Excellence in Project Management
Medical Products, Medical Devices, and R&D
Delivering Excellence in Project Management
Our Services
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End-To-End Project Management
Experienced and effective PM support catered to the needs of the project and company.
Regulatory Affairs Project Management
Regulatory affairs support provided by RAC certified professionals.
CMC Writing & PM Support
Partner services to support CMC & BLA dossier writing and project management activities for biologics and drug submissions.
Medical Writing
Develop precise and effective documentation services.
Our Services
Click Tiles To Learn More
End-To-End Project Management
Experienced and Effective PM support to provide end-to-end services for asset development.
Regulatory Affairs Project Management
Regulatory affairs support provided by RAC certified professionals.
CMC Project Management
Partner with the CMC team to provide seamless project management activities supporting overall regulatory strategy.
Medical & Technical Writing
Develop precise and effective documentation services.
Our Team
Shailaja's (Shai) expertise lies in identifying the strategic and operational roadblocks and working with the resources at hand to carry out successful regulatory submissions.
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.
About Us
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
Our objective is to give you a competitive advantage by identifying the most effective pathway to regulatory submission and approval for your therapeutic asset.
This efficiency is a testament to our commitment to your success.
About Us
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
Our objective is to give you a competitive advantage by identifying the most effective pathway to regulatory submission and approval for your therapeutic asset.
This efficiency is a testament to our commitment to your success.
Identify Key Stakeholders
Develop a Compelling Story
Cross-Functional Analysis & Plan Development
Employ Regulatory Strategy to Streamline Build
Identify Critical Path
Optimize Draft and Review Timeline
Systematize Document Management System for Data Integrity
Finalize & Establish Rolling Publishing Workflow
Full Process Breakdown
1. Identify key stakeholders
2. Work with the stakeholders to develop a compelling narrative with a concise storyboard
3. Work with cross-functional teams to optimize upstream workflows including building a TPP, competitive analysis, critical HA interactions, study protocol, Statistical Analysis Plan, Clinical developmental plan, etc
4. Work with other CROs and vendors to iron out key deliverable dates
5. Work with Regulatory strategy and internal or external Medical Writers (We also provide Medical Writing support) to streamline the build of clean and lean submission dossier using the narrative and messaging
6. Optimize draft and review timelines to ensure no wasted time and backtracking
7. Work in the Document Management System to ensure content and data integrity
8. Work closely with the publishing team to establish a system for rolling publishing.
Our Mission
Position Your Biotech Asset for Success Using The Project Management Toolkit
Position Your Biotech Asset for Success Using The Project Management Toolkit ...more
Main
September 05, 2024•2 min read
Safety Reporting Through PSUR/PBRER
SAFETY REPORTING THROUGH PSUR/PBRER ...more
Main
September 05, 2024•2 min read
Major USFDA Regulatory Updates in December 2022
Major USFDA Regulatory Updates in December 2022 ...more
Industry Updates
September 05, 2024•2 min read
Full Process Breakdown
1. Identify key stakeholders
2. Work with the stakeholders to develop a compelling narrative with a concise storyboard
3. Work with cross-functional teams to optimize upstream workflows including building a TPP, competitive analysis, critical HA interactions, study protocol, Statistical Analysis Plan, Clinical developmental plan, etc
4. Work with other CROs and vendors to iron out key deliverable dates
5. Work with Regulatory strategy and internal or external Medical Writers (We also provide Medical Writing support) to streamline the build of clean and lean submission dossier using the narrative and messaging
6. Optimize draft and review timelines to ensure no wasted time and backtracking
7. Work in the Document Management System to ensure content and data integrity
8. Work closely with the publishing team to establish a system for rolling publishing.
Our Mission
Position Your Biotech Asset for Success Using The Project Management Toolkit
Position Your Biotech Asset for Success Using The Project Management Toolkit ...more
Main
September 05, 2024•2 min read
Safety Reporting Through PSUR/PBRER
SAFETY REPORTING THROUGH PSUR/PBRER ...more
Main
September 05, 2024•2 min read
Major USFDA Regulatory Updates in December 2022
Major USFDA Regulatory Updates in December 2022 ...more
Industry Updates
September 05, 2024•2 min read
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