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AccelerateAI offers cutting-edge solutions for regulatory and medical writing, submissions, and strategic guidance. Join us in revolutionizing the industry.

AI for Regulatory Approvals
Deep Research in Drug Development

AccelerateAI pioneers the fusion of deep science and AI on a transformative scale. Our expertise lies in enhancing drug innovation through AI-powered regulatory strategies. Leveraging deep learning, extensive regulatory knowledge, and biomarker insights, we optimize FDA compliance and expedite submissions. We drive success in the rapidly evolving biotech sector, ensuring our clients stay ahead in the dynamic landscape of innovation.

Our Services

Model

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Accelerate AI
Data Science

RWE

AI Predictive Analysis

AI Data Visualization

Validated Clinical Endpoints, Validated Predictive Decision making for Biomarker strategy

Predictive Analysis for Efficacy and Safety endpoints 

Data Programming - R, Python​

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AccelerateAI

Regulatory Strategy

Our curated tech stack includes: AlphaFold 3; NVIDIA BioNeMo Cloud; Semantic Scholar and ATOM Modeling Pipeline (AMP). Drawing on decades of Regulatory Strategies, we help biotech teams strategize regulatory approach

3

Accelerate AI

Deep Research

Deep Science Meets AI at Scale. We are Drug Innovators who use Rapidly Accelerating AI Landscape for Regulatory Strategy with FDA breakthrough . Accelerate Biotech Innovation using exponential AI growth, leveraging the Deep Learning to drive exact science in Regulatory Research, Decades of Regulatory Strategies

4

Accelerate AI

Literature Evaluation

Built for the Breakneck Speed of Biotech Innovation and exponential AI growth, leveraging the latest in Deep Learning and AI-powered platforms to drive smarter Regulatory Research, Accelerate Drug Discovery, and Support complex therapeutic Regulatory strategies in oncology and immunology.

AccelerateAI
Features That Maximize Your Regulatory Efficiency

Advisory & FDA Meeting Readiness

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Our  Story

We are a Pharma and Biotech Regulatory consulting business started in 2023, backed by 70+ years of combined expertise. Our seasoned senior advisors provide strategic solutions for FDA, and global regulatory approvals. We were founded with one mission: to simplify the regulatory journey for companies advancing the frontiers of biotech and pharmaceutical innovation. With years of experience in FDA and EMA interactions, scientific advisory, and regulatory documentation, we help our clients de-risk development programs and achieve timely approvals. Whether someone's an early-stage startup or a growing global company, we provide customized solutions built on integrity, expertise, and results.

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Innovative

AccelerateAI excels in leveraging cutting-edge technologies like AlphaFold 3 and BioNeMo to drive regulatory strategy and accelerate drug discovery.

Expert Team

Our team of seasoned professionals with decades of experience aligns biomarker strategy and submissions to FDA expectations for successful outcomes.

Tailored Solutions

At AccelerateAI, we provide customized solutions using tools like Semantic Scholar and AMP to support complex therapeutic development for our clients.

Strategic Partnerships

We collaborate with industry leaders to ensure our clients receive the most advanced and effective services, delivering success at unprecedented speed.

Meet Our Team

Discover AccelerateAI's exceptional consultants who lead with expertise and innovation. Our team of professionals is dedicated to delivering top-tier solutions tailored to your business needs.

Experts

Specialists

Our experts bring a wealth of knowledge and experience to the table, guiding clients through complex challenges with precision and insight.

Consultants

Innovators

Meet our dedicated consultants who work tirelessly to analyze data, develop strategies, and drive business transformation for our clients.

Analysts

Strategists

Our team of analysts dives deep into data to uncover valuable insights that empower our clients to make informed decisions and stay ahead of the curve.

Latest Posts

Our Story

Founded in 2024, AccelerateAI is a regulatory affairs consulting company specializing in biotech and pharmaceutical regulatory approvals. With AI-driven innovation, we expedite regulatory pathways and offer strategic guidance.

Who We Are

At AccelerateAI, we are dedicated to leveraging cutting-edge technologies and expertise to empower biotech and pharmaceutical innovators.

Our Mission

Our mission is to accelerate regulatory processes, enhancing the success of life science innovators through strategic solutions.

Client Stories

AccelerateAI transformed our regulatory processes, providing invaluable solutions for our FDA approvals.

Michelle T.

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