Products / Services
  • Products / Services
  • Companies
  • Buy Leads
    Post Buy Requirement

    Pharmaceutical Regulatory Services

    • Business TypeService Provider
    • Preferred Buyer Location All over the world

    Rudra marketing solutions is one of the reputed companies based in Ahmedabad (Gujarat, India) engaged in providing pharmaceutical regulatory services in India. We are supported by a team of experts....
    View More Details
    Send Enquiry

    Company Information

    • calendar Member Since 7 Years
    • building Nature of Business Retailer
    • gst icon GST No. 24AAUFR2258K1ZO

    Ask for more detail from the seller

    Contact Supplier
    Report incorrect details
    • Service Details

    • Company Details

    no_img_icon

    Rudra marketing solutions is one of the reputed companies based in Ahmedabad (Gujarat, India) engaged in providing pharmaceutical regulatory services in India. We are supported by a team of experts who execute these services, according to the requirement of our worthy clients. We help the pharmaceutical companies stay one step ahead of regulatory changes, and upgrade their end-to-end regulatory activities. We provide services for good manufacturing practices (GMP), validation, training and documentation, drug master file (DMF), mock audits and many others, as per regulatory requirements. Widely acknowledged for efficiency, responsiveness, strategy and for being personalized, the services that we offer are one of the best in this industry. Get in touch with us to avail our pharmaceutical regulatory services at a budget-friendly price.

     

    Some Key Facts about Our Technical Team & Working Module:

    • Having more than 15 Years of Experience
    • Can provide full support from Dossier Compilation to Submission.
    • Stand with Client till Product Approval without any Additional Charges.
    • Standard Charges for each Service.
    • Prefer to have Tele conference with Client before proceeding ahead with any Project, for better understanding.


    Structure

    SR NO.REGULATORY SERVICESMARKET
    1ADMINISTRATIVE 
    AProcedure ManagementAll
    BCommunication with MOH
    CeCTD Conversion
    DRegulatory Training
    EUSER TestingEU
    2TECHNICAL 
    A

    Development Support

    • Designing of Specification
    • Pharmaceutical development Report Review (PDR)
    • DMF Review/ Technical pack Review
    • Packaging material selection
    All
    BPreparation, Compilation & Review of 2.4 & 2.5 Module ((For Generic/Hybrid/Bibliographic application)EU
    CPreparation, Compilation & Review of Risk Management Plan (RMP)
    DReview of RTR (Refuse to receive standard) as per RTR GuidelineUS
    EReview of Dossier as per ANDA Checklist
    FReview of BA/BE Study as per MOH GuidelineAll
    GDue Digilance of Dossier
    3POST – APPROVAL 
    AVariation Filing / Supplement FilingEU/US
    B

    Pharmacovigilance Services

    • PSUR / PABER
    • Literature Review
    • Aggregate Report Compilation
    • EVMPD Database Entry
     
     
     
     

    Service Images

    • Pharmaceutical Regulatory Services
    • Pharmaceutical Regulatory Services
    Share your requirements for a quick response!
    Tell us what you need?

    By clicking Get Quotes Now, I accept the T&C and Privacy Policy.

    Looking for Pharmaceutical Regulatory Services?

    Quantity
    Contact Details
    Waiting for permission
    To search by voice, go to your browser settings and allow access to microphone

    Allow microphone access to search with voice