Pharma Regulatory Affairs


DMF Preparation, NCO/CO Overview, CTD/eCTD Dossier Conversion, Filing Strategy, Life-cycle Management, Licenses

Regulatory Documentation
    • Drug Master File, Variation Application
    • Clinical/Non-clinical Overview
    • CTD/eCTD Dossier Conversion
    • Technical Documents, Scientific Justifications
    • CTD dossiers (ASEAN, EU, USA, Canada, Australia, WHO PQ)


Strategy, Assessment & Due Diligence
    • Strategies for EU/ US/AU/ROW Filings
    • Gap Analysis and Dossiers Upgradation
    • CDSCO and State FDA Licenses
    • WHO Prequalification for API and FPP
    • Lifecycle Management -Variation, Extension, New Dosage Forms

Pharma Regulatory Affairs Services

Achieve unparalleled regulatory compliance and expedite market approvals with our comprehensive Pharma Regulatory services. From Drug Master File to Clinical/Non-clinical Overviews and Technical Documents, our expertise spans every aspect of regulatory affairs.

Experience seamless transitions to global standards with our CTD/eCTD Dossier Conversion services, ensuring your submissions meet regulatory requirements worldwide. Navigate regulatory complexities with confidence through our Strategies for EU/US/AU/ROW Filings, tailored to ensure success across diverse regions. Drive innovation and growth with our Gap Analysis and Dossiers Upgradation services, enhancing your regulatory readiness. Secure CDSCO and State FDA Licenses seamlessly with our expert guidance.

Position your products for global success with WHO Prequalification for API and FPP, bolstering your reputation for quality and reliability. Harness the full potential of your pharmaceutical products through Life Cycle Management services, encompassing Variation, Extension, and New Dosage Forms.

Partner with us to unlock the full potential of your regulatory compliance efforts and accelerate your path to market success.

For details; contact Dr Sanjay Bajaj, E:; M: 7696525050

Other Services

Lead Generation

Research, Instruments, Products, Services and Webinar Promotion to Scientific Communities

Industry Solutions

Technical, Research & Regulatory Solutions for Pharma, Clinical & Other Industry R & D Scientists

Regulatory Affairs

Dossier Preparation, CTD/eCTD Submission, Lifecycle Management, Regulatory Strategies

Virtual Assistant

Document Services, eCTD Documentation, Design, Business, Administrative and Management Services


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