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Wednesday 11 May 2016

Kanupriya Budhiraja

Kanupriya Budhiraja

Kanupriya Budhiraja

Sr. Manager - DRA at Synokem Pharmaceuticals Ltd


links
  • https://in.linkedin.com/in/kbudhiraja

     https://www.facebook.com/kanubudhiraja
     https://twitter.com/kanubudhiraja
     https://plus.google.com/114108592663419658404/about

    Summary

    • A seasoned pharmaceutical consultant having around 10 years of progressive experience with many reputed Pharma & Healthcare companies
    • A qualified Regulatory Affairs Professional possessing a Post Graduate Diploma in Drug Regulatory Affairs and Gold Medallist in Post Graduation
    • Expertise in Regulatory submissions for Regulated, Semi-regulated & ROW markets
    • Well versed and updated with CTD, ACTD, ICH, GMP& other Guidelines
    • Experience with wide range of Pharmaceutical and Ayurvedic products in various dosage forms – tablets, capsules, syrups, suspensions, dry powders, creams and ointments, Ophthalmic and Otic drops, etc.

     

    Experience


    Sr. Manager - DRA

    Synokem Pharmaceuticals Ltd
     – Present (11 months)New Delhi Area, India

    Freelance Regulatory Consultant

    Reguserv Consulting
     –  (10 months)New Delhi Area, India
    - Providing end-to-end technical solutions regarding various aspects of pharmaceutical products – from its inception till launch.
    - Preparation of registration dossiers for submission in Ministry of Health for the purpose of overseas registration & exports
    - Preparation of Applications for submissions in CDSCO & DCGI Offices for registration & approvals in India
    - Liasoning with Drug Offices
    - Preparation of Drug Master Files for APIs
    - Regulatory Query handling
    - Assistance for developments of technical documents & business strategies
    - Providing assistance in conducting Clinical trials/ BA-BE studies

    Manager - Regulatory Affairs

    Gracure Pharmaceuticals Ltd.
     –  (3 years 2 months)new delhi area, india
    - Registration of pharmaceutical products in various countries across the globe - Kenya, Botswana, Myanmar, Madagascar, Ukraine, Cambodia, etc.
    - Guiding team members for development of CTD registration dossiers
    - Review of Artwork for pharmaceutical products for various countries
    - Coordination with QA/ QC departments
    - Troubleshooting in Regulatory Affairs

    Assistant Manager - Regulatory Affairs

    Ozone Group
     –  (1 year 3 months)
    - Preparing Regulatory Dossiers & other Export documents for
    ayurvedic & pharmaceutical products
    - Preparing Detailed Project Reports (DPR) for future
    expansion of Ozone Group
    - Review of Quality Documents
    - Review of Domestic & Exports artworks
    - Liasoning with govt. bodies like NPPA, MoEF, etc.


    Sr. Executive - Regulatory Affairs

    Sentiss Pharma Pvt. Ltd. (Formerly Promed Exports Pvt Ltd)
     –  (2 years 2 months)
    Preparation of dossiers for registration of pharmaceutical products in Russia & CIS countries on CTD Format


    Executive - Regulatory Affairs

    LG Life Sciences
     –  (7 months)
    Documentation for Import and Registration of Bio-medical products and medical devices in India
    Compilation and submission of dossiers as per Indian regulatory guidelines and handling queries
    Providing technical and regulatory information support to LG Life Sciences, Korea
    Successfully faced Local FDA Audits

    Trainee Executive - Quality Control

    Torrent Pharmaceuticals Ltd
     –  (1 year)
    Preparation of documents as per cGMP, ISO 17025:2005 and as per in-house guidelines
    Preparation of QMS documents like Quality Manual, Quality Procedures & Quality Formats
    Managing communication with NABL Accreditation body
    Successfully faced the NABL Audit

    Honors & Awards

    Gold Medalist


    Education


    Gurukula Kangri Vishwavidyalaya

    M.Sc, Chemistry

    University Gold Medallist
    (Open)1 honor or award

    Delhi Public School






 


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Anne Steinkamp

,
Anne Steinkamp
RWTH Aachen University - Chair of Organic Chemistry II
 

Anne-Dorothee Steinkamp

https://de.linkedin.com/in/anne-dorothee-steinkamp-56606a115
https://www.facebook.com/annedorothee.steinkamp
https://www.researchgate.net/researcher/2071216041_Anne-Dorothee_Steinkamp
 








Map of RWTH Aachen
RWTH Aachen University 
University in Aachen, Germany
RWTH Aachen University or Rheinisch-Westfälische Technische Hochschule Aachen is a research university located in Aachen, North Rhine-Westphalia, Germany. Wikipedia











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Laura Buglioni

Laura Buglioni

RWTH Aachen University, Institute of Organic Chemistry, Landoltweg 1, 52074 Aachen, Germany, Fax: (+49) -241-809-2391
RWTH Aachen University - Chair of Organic Chemistry II






FACEBOOK.....Laura Buglioni




















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