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www.ascentcoaipharma.com
www.ascentcoaipharma.com

  • AscentCoAI Pharma : 
    AI-Driven Pharma Excellence — Powered by Human Expertise

    Scientific and Regulatory Documentation, Technical Support, Compliant Sourcing, and Strategic Talent Solutions.

    AscentCoAI Pharma is a Human + AI–driven solutions platform for the pharmaceutical, healthcare, and life-sciences industries. We combine over two decades of deep regulatory expertise with cutting-edge AI to deliver comprehensive support that accelerates your success.

    How We Help You:

    ✅Navigate the Complete Product Lifecycle

    — From formulation & analytical development, BE studies, and method validation, through to global regulatory submission (FDA/EMA/WHO) and audit readiness.

    ✅ Streamline Quality & Compliance Systems 
    — Accelerate documentation for R&D, Analytical, QC, Investigations, and CAPA with AI-enhanced systems.

    ✅ Secure Top-Tier Talent

    — Recruit expert R&D, QC, and Regulatory professionals using our smart AI–human hybrid hiring model.

    ✅ Source with Confidence & Cost-Efficiency

    — Access APIs, excipients, and lab materials through our vetted, global network of GMP-compliant suppliers.

    Our integrated solutions deliver speed, precision, and quality — from lab to launch.
    We do not manufacture products.
    We empower companies, laboratories, and startups with the scientific, regulatory, and operational expertise to bring products to market faster and with greater compliance.

    Get Your Free Compliance Efficiency Audit

  • Cut Compliance Time by 50% with AI-Powered Pharma Solutions
    ​​Fast-Track FDA Submissions, Talent Recruitment and Global Sourcing

    AscentCoAI Pharma delivers measurable impact with every engagement:

    ⚡ Faster Approvals: AI-enhanced documentation and audit readiness
    ⚡ Smarter Teams: Hybrid AI-human hiring for R&D, QC & regulatory talent
    ⚡ Trusted Sourcing: Pre-qualified GMP suppliers for APIs, excipients & materials

    Whether you're preparing for FDA audits, scaling your team, or sourcing critical materials — our AI-led approach ensures precision, speed, and peace of mind.

    Get Your Free Compliance Gap Analysis
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About us

AI-Powered Pharma Excellence: Quality-Driven, Compliance-First

  • Compliance & Quality Systems: End-to-end GxP documentation support, third-party audit management, investigation support (Root Cause Analysis), and CAPA management.

  • Talent & Resourcing: Building high-performing teams for R&D, Quality, and Manufacturing units.

  • Sourcing & Supply Chain: Securing GMP-compliant materials and building resilient supply chains.

  • R&D, Quality & Manufacturing Enablement: High-level drafting and documentation support for research projects and manufacturing processes to ensure regulatory readiness from the start.

Our Vision 
​To lead the future of AI-driven pharma solutions by transforming compliance, talent, and sourcing while continuously advancing innovation, collaboration, and global impact.
Our Mission 
​To empower pharma and biotech companies with expert strategies and AI-powered tools that ensure agile compliance, top-tier talent, secure sourcing, and a connected ecosystem for research collaboration, innovation, and social responsibility.
Our Values 
Patient-Centric Integrity | AI-Powered Intelligence | Relentless Compliance | Collaborative Innovation | Shared Growth
→ "Discover Our Purpose"

Our services

AI-Driven Pharma Solutions for Faster Approvals and Operational Excellence

From analytical R&D documentation, Technical support, and regulatory compliance to expert recruitment and GMP material sourcing, AscentCoAI Pharma empowers pharmaceutical and biotech companies to reduce time-to-market, mitigate risk, and lower costs through intelligent, AI-powered solutions.

Buying assistance
📄 1. Formulation Analytical R and D | QC/QA Technical and RegulatoryDocumentation Support 

We provide end-to-end R&D and quality support for regulated markets, enabling faster, compliant product development.
  • Formulation & Analytical R&D support

  • QC/QA technical documentation,

  • Investigations, Gap Assessment & CAPA

  • BE studies

  • Validation protocols

  • Audit-ready SOPs

  • CMC & dossier compilation

  • eCTD  assistance

  • Tech/Site transfer documentation 

🔗 [Build Your Dream Team →]
Project Planning
🧠2. Talent and Workforce Solutions

AI-Hybrid Recruitment for Critical Pharma Roles


Roles: R&D, QC/QA, Regulatory, Manufacturing

·Smart Matching: AI-powered vetting + human validation

Global Reach: Pre-screened professionals for niche pharma expertise.
✅Reduce hiring time by up to 40% with our validated pipeline

🔗 [Streamline Your Compliance →]
Site Management
🌐3. Trusted Global Network for GMP-Certified Supplies and Documentation Support

APIs • Excipients • HPLC Columns • Laboratory Reagents

Vetted Vendor Qualification + Complete Regulatory Documentation Support

Risk-Free, Globally Compliant Sourcing
✅ Cost-effective procurement with 100% GMP alignment


🔗 [Optimize Your Sourcing →]
Legal support
🧪 4. Dissolution and BE Study Assistance

  • End-to-End Support for Bioequivalence and Compliance

      • Protocol Design, In-Vitro/In-Vivo Correlation

      • Method Development support

      • BE Report Compilation for FDA/EMA Submissions
        ✅ Ensure flawless BE study execution for faster approvals



🔗 [Validate Your Formulations →]
Interior Design
🧪 5. Quality Control and Analytical Method Validation

AI-Assured Precision for Modern QC Labs

  • Analytical Method Development and Validation

  • Stability Testing documentation, investigations, Optimized SOPs

  • ALCOA+ Compliance & Audit-Ready Documentation
    ✅ Achieve 100% audit-readiness with AI-powered data integrity and error detection.

🔗 [Strengthen Your QC →]
Market analysis
🌍 6. Regulatory Intelligence and Market Access

Navigate Global Markets with Confidence

  • Real-Time Monitoring: FDA, EMA, ICH Guideline Updates

  • Competitor Approval & Pathway Intelligence

  • AI-Powered Regulatory Alerts

  • Market Entry Strategy & Support
    ✅ Stay ahead of evolving regulations and accelerate global access.

🔗 [Navigate Global Markets →]

21+

Two decades in Regulatory and Analytical R and D

300+

Products Handled (including API, excipient, and finished dosage forms)

50+

Successful F2 Study Documentation Projects

Experience across multiple formulations:


🔷 Shaping the Future of Pharma—One Step at a Time

At AscentCoAI Pharma, we merge over two decades of regulatory excellence with AI-powered innovation to deliver faster, smarter, and more compliant pharmaceutical solutions.
From global regulatory filings and F2 documentation to formulation support and tech transfer, our mission is to simplify complexity and accelerate growth for pharmaceutical businesses of all sizes.
👉 Build with us the next era of intelligent, compliant, and cost-effective pharma operations.

→ “Shape the Future With Us”

✅Why Partner With Us?

At AscentCoAI Pharma, we bring two decades of hands-on expertise in regulatory, R&D, and tech transfer—merged with cutting-edge AI-driven solutions.

We help pharmaceutical and healthcare companies accelerate product approvals, optimize compliance, and reduce operational risks through smart documentation, sourcing, and technical consulting.


Our services are shaped by real-world experience, ensuring efficiency, accuracy, and future-ready operations tailored to global regulatory standards.

Our core team has contributed to regulatory and analytical successes at renowned pharmaceutical organizations like FDC, Cipla, Centaur, Unichem, and Abbott.

This diverse, multinational experience strengthens our ability to deliver global-quality solutions for today’s evolving pharma landscape.


2004

Drove Regulatory-Focused Rand D and Tech Transfers Across Unichem and Abbott

Led analytical R&D, BE study support, ANDA filings, and global regulatory submissions at Unichem. At Abbott, spearheaded AR&D, site transfers, and cross-functional tech ops for regulatory market success.


2014

Founding AscentCoAI: Future-Ready Solutions

Leveraged decades of domain expertise to establish AscentCoAI Pharma, a knowledge-driven venture offering regulatory, documentation, sourcing, and AI-integrated consultancy solutions for the pharma, healthcare, and chemical industries.

Building a Foundation in Pharma Quality

Commenced career in QC/QA at FDC & Cipla Ltd., mastering regulatory compliance and quality assurance in pharmaceuticals, crucial for precision and structured methodologies

2007

Leadership and Growth

At Centaur Pharmaceuticals, leveraged cumulative experience to drive innovation and operational excellence, solidifying expertise in cross-functional roles.

2025
​

Meet our experts

Trusted Experts. Proven Experience. Collaborative Impact.
​At AscentCoAI Pharma, our strength lies in deep, cross-functional expertise—built through partnerships with industry veterans who’ve led regulatory success stories, tech transfers, and quality transformations across global markets.



Hemant Patil

Founder | R&D, Regulatory & Quality Strategy

Know more

Dr. Sudhir Kumbhar
QA/QC & Compliance Advisor

Know more

Nandkumar Phadtare
Manufacturing & Tech Transfer Consultant

Know more




Customer testimonials

Their deep regulatory knowledge helped streamline our complex filing process—saving us both time and resources.

AscentCoAI Pharma proved to be a reliable partner in API sourcing, formulation support, and tech transfer for our product pipeline.
👉 Discover how we’ve helped pharma teams accelerate compliance, enhance R&D outcomes, and achieve success in critical operations across global markets.

→ “Read More Success Stories”
Hemant Patil

Founder | R&D, Regulatory & Quality Strategy

  • Over two decades of experience in Formulation analytical R&D, and  Quality, CMC submissions (USFDA, EMA, MCC, Health Canada, and TGA).

  • Ex-Cipla Ltd., , Abbott India Ltd., Abbott Healthcare Pvt.Ltd, Centaur Pharma. Pvt Ltd., Unichem Lab. Ltd., FDC Ltd., RCC Pvt Ltd.

  • Specialist in complex generics, site transfers, regulatory gap analysis, and ANDA documentation.

    • Dr. Sudhir Kumbhar

    QA/QC & Compliance Advisor

    • 22+ years in QA/QC, CQA, and GMP audit readiness for API and formulation sites

    • Ex-Pfizer Ltd.:, USV Ltd., SUN Pharmaceutical Ltd., Unichem Lab. Ltd., IPCA Lab., Harman Finochem,Themis Medicare

    • Led 50+ vendor audits, faced 20+ regulatory audits (USFDA, EDQM, MHRA, TGA, KFDA) and known for 483 response strategies

    Nandkumar Phadtare

    Manufacturing & Tech Transfer Consultant

    • 23+ years in FDA-compliant manufacturing (sterile/orals) and PPIC

    • FDA approved in Tablets

    • Ex-Ajanta Pharma Ltd., FDC Ltd., Blue Cross Lab. Ltd., Raptakos, Brett&Co.Ltd., Flemingo Pharm. Ltd.

    • Led 15+ successful tech transfers, production setup, and CMO alignment across top pharma companies



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