Experience That Matters
All The Specialties Your Team Needs.
Slow is Smooth, Smooth is Fast
End-To-End Project Management
Today, a pharmaceutical company's global reach and a successful multinational product launch hinge on an iterative global regulatory project plan. This plan enables the execution of a regulatory strategy for navigating the dissonance of competing local laws and regulatory requirements.
We will work with your team to ensure that the ultimate goal of a successful marketing application is always a central defining feature of every stage of product development and not an afterthought.
Today, a pharmaceutical company's global reach and a successful multinational product launch hinge on an iterative global regulatory project plan. This plan enables the execution of a regulatory strategy for navigating the dissonance of competing local laws and regulatory requirements.
We will work with your team to ensure that the ultimate goal of a successful marketing application is always a central defining feature of every stage of product development and not an afterthought.
We've Got You Covered:
1. Identify key stakeholders
2. Cross-Functional Analysis and Plan Development
3. Refine regulatory strategy
4. Optimize upstream workflows
5. Devise project timelines
6. Identify gaps and assess risks
7. Continuously refine to ensure timely regulatory submission
We've Got You Covered:
1. Identify key stakeholders
2. Cross-Functional Analysis and Plan Development
3. Refine regulatory strategy
4. Optimize upstream workflows
5. Devise project timelines
6. Identify gaps and assess risks
7. Continuously refine to ensure timely regulatory submission
Failing to Plan, Is planning to fail
Regulatory Affairs Project Management
A successful marketing application builds on several regulatory submissions: pre-IND interactions, IND/CTA submissions, other health authority engagements, and pre-submission meetings. Each submission and interaction requires careful strategizing and project planning.
We will use our proven 'dynamic criticality and messaging' methodology to identify the critical path to the fastest submission and health authority review scenario.
We've Got You Covered:
1. Develop a Global Regulatory Plan
2. Identify upstream deliverables
3. Refine global health authority interaction strategy
4. Build submission timelines
5. Build, align, and refine key messages, target product profiles, and narratives
5. Optimize timelines to remove redundancies
7. Identify gaps, assess risks, and establish contingencies and scenarios
8. Continuously refine
We've Got You Covered:
1. Develop a Global Regulatory Plan
2. Identify upstream deliverables
3. Refine global health authority interaction strategy
4. Build submission timelines
5. Build, align, and refine key messages, target product profiles, and narratives
5. Optimize timelines to remove redundancies
7. Identify gaps, assess risks, and establish contingencies and scenarios
8. Continuously refine
A successful marketing application builds on several regulatory submissions: pre-IND interactions, IND/CTA submissions, other health authority engagements, and pre-submission meetings. Each submission and interaction requires careful strategizing and project planning.
We will use our proven 'dynamic criticality and messaging' methodology to identify the critical path to the fastest submission and health authority review scenario.
Experience Matters
CMC Project Management
CMC changes are expected and integral to product development from discovery candidate to first-in-human to market. We will work with your CMC, supply chain, and manufacturing teams to develop an executable and situation-specific project plan that will support drug evolution and incorporation of pre-approval and post-approval changes.
CMC changes are expected and integral to product development from discovery candidate to first-in-human to market. We will work with your CMC, supply chain, and manufacturing teams to develop an executable and situation-specific project plan that will support drug evolution and incorporation of pre-approval and post-approval changes.
We've Got You Covered:
1. Work with GRA to identify CMC milestones, such as Clinical material formulations, process validation, scale-up, and commercial manufacturing.
2. Identify and align on CMC assumptions impacting clinical and regulatory plans and timelines.
3. Integrate the CMC project plan with the submission plan.
4. Refine and adjust via numerous meetings and discussions.
We've Got You Covered:
1. Work with GRA to identify CMC milestones, such as Clinical material formulations, process validation, scale-up, and commercial manufacturing.
2. Identify and align on CMC assumptions impacting clinical and regulatory plans and timelines.
3. Integrate the CMC project plan with the submission plan.
4. Refine and adjust via numerous meetings and discussions.
its all in the details
Medical & Technical Writing
We provide Medical and technical writing services. Our writers work closely with key stakeholders (Biostats, Clinical Operations, Programming, Regulatory Strategy, Program Managers) to develop key messaging and effective regulatory documentation.
We've Got You Covered:
1. Establish Medical Writing Submission Deliverables
2. Build and continuously refine key messages
3. Identify and optimize timelines for upstream data deliverables
4. Build Shells
5. Write, Review, and Refine
6. Cohesive messaging across reports and modules
7. Simultaneous writing to accelerate time to submission
We've Got You Covered:
1. Establish Medical Writing Submission Deliverables
2. Build and continuously refine key messages
3. Identify and optimize timelines for upstream data deliverables
4. Build Shells
5. Write, Review, and Refine
6. Cohesive messaging across reports and modules
7. Simultaneous writing to accelerate time to submission
We provide Medical and technical writing services. Our writers work closely with key stakeholders (Biostats, Clinical Operations, Programming, Regulatory Strategy, Program Managers) to develop key messaging and effective regulatory documentation.
STILL NOT SURE?
Frequently Asked Questions
Our industry is complicated. Let's make it easier.
How do does it work to contract Antero?
Please reach out to us and schedule a 25-minute introductory call. We will ask a couple of questions to understand your exact needs. We will then revert with a bespoke plan and draft SOW. We will schedule another meeting (or meetings, as needed) and go from there.
At what developmental stage should we contact you to ensure a successful regulatory submission?
Any time! The earlier, the better!We work with and for you on projects that span pre-IND, IND/CTA, BLA, sBLA, etc. Depending on the asset's stage, we will develop a plan that works with available resources, time, and financial constraints to ensure a compliant, effective, and efficient submission.
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