Delivering Excellence in Project Management

Medical Products, Medical Devices, and R&D

Delivering Excellence in Project Management

Our Services

Regulatory Affairs Project Management

Regulatory affairs support provided by RAC certified professionals.

Project Management

Experienced and effective PM support catered to the needs of the project and company.

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.

Clinical Research & Medical Affairs

Compilation and Data Analysis of Clinical Data along with QC/QA checks, compliant to GCP standards.

R&D Support

Research project expertise in neurology, autoimmunity, auto-inflammatory, and immune-oncology disease areas.

Our Services

Project Management

Experienced and effective PM support catered to the needs of the project and company.

R&D Support

Research project expertise in neurology, autoimmunity, auto-inflammatory, and immune-oncology disease areas.

Regulatory Affairs Project Management

Regulatory affairs support provided by RAC certified professionals.

Clinical Research

Compilation and Data Analysis of Clinical Data along with QC/QA checks, compliant to GCP standards.

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 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

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

Resource Blog

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Position Your Biotech Asset for Success Using The Project Management Toolkit ...more

Main

September 05, 20242 min read

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Safety Reporting Through PSUR/PBRER

SAFETY REPORTING THROUGH PSUR/PBRER ...more

Main

September 05, 20242 min read

Safety Reporting Through PSUR/PBRER

Major USFDA Regulatory Updates in December 2022

Major USFDA Regulatory Updates in December 2022 ...more

Industry Updates

September 05, 20242 min read

Major USFDA Regulatory Updates in December 2022

Expanded Access Program - overview and notes

Expanded Access Program - overview and notes ...more

Main

September 05, 20242 min read

Expanded Access Program - overview and notes

Major USFDA Regulatory Updates in April 2023

Major USFDA Regulatory Updates in April 2023 ...more

Industry Updates

September 05, 20242 min read

Major USFDA Regulatory Updates in April 2023

Lets Talk

Connect With Us

(408)-409-9381

Lets Talk

Connect With Us

(408)-409-9381

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© Copyright 2024 Antero Inc. All Rights Reserved.

Terms of Use | Privacy Policy | Cookie Policy

© Copyright 2024 Antero Inc. All Rights Reserved.