Aurous healthcare

Regulatory Affairs

AHC have been immensely successful in obtaining regulatory approvals for clinical development and commercial manufacturing of pharmaceutical, biologic and medical device products. We provide the most effective regulatory assessment and strategy for all stages product development and life cycle management.

We offer Regulatory Affairs as follows, but not limited to:

  • Obtaining DCGI approval / notification
  • Regulatory dossiers for various submissions including ACTD, EUCTD, USFDA and ROW
  • Preparation of Periodic Safety Update Report (PSUR), Company Core Data Sheet (CCDS) and Development Safety Update Report (DUSR)

News

News

  • Article in The Hindu - BUSINESS LINE (March 10, 2014; Pg 18) detailing about R & D partnership of Aurous Healthcare for one of our primordial client- Dhathri Group Readmore..
  • “Article in Deccan Chronicle Chennai (04-Aug-13 Pg26) on the health benefits of Collagen Peptide by Dr. VT.Sriraam” Download Article

  • Public awareness article written by our Managing Director Dr. V. T. Sriraam, M.B.B.S, M.D. published in Tamil Daily "Thinathanthi" on 03-Feb-13. Download Article

  • We are awarded as “The most promising Healthcare R&D Company from Chennai, Tamil Nadu” by BIG research, a brand finding organization from Delhi with its media PartnerNDTV Profit.
    You tube Link: http://youtu.be/eMW1VeSzp2M

  • For the first time in the arena of Clinical Research Academy of India, our academic division “Auro Academy of Education and Research” launches a course in clinical research “Fellowship in Clinical Research Management” with 100% Job Guarantee (14 months work experience as CRA/CRC in our CRO).
    Link: http://auroushealthcare.com/pdf/AAER%20BROCHURE.pdf

  • We have set records in successful completion of two phase III trials on Osteoarthritis on collagen peptide, undertaken from an Indo Japan client and the product Gelixer has got launched successfully into the market
    Link: :http://www.gelixer.com/medical_professionals.asp http://www.youtube.com/watch?feature=player_embedded&v=YoybGsbsQno#!

  • Undertaking of a drug discovery and drug development – End to End project: We have successfully completed formulation and development and animal studies of a FDC (Fixed dose combination) project in Ophthalmology for an Indo MNC. Clinical trial is to be commenced shortly.

  • Ongoing clinical trial projects:
    • Phase III b trial on Osteoporosis
    • Phase III b trial on Dysmennorrhea
    • Dermatological trial on coloring agents
    • 6 Phase IV trials on herbal cosmeceuticals

  • We have completed a two animal toxicity study for FDC (fixed dose combination) in ophthalmology.

  • We have successfully completed the 2nd Surveillance Audit for ISO 9001:2015 certification for Quality Management System.

  • Our Medical Director, DR. V.T. Sriraam, M.D (Pharmacology), has presented a topic in 2011 International Conference on Food Factors on RCT to prove effectiveness and safety of Colla Pep JP and Colla Pep PU dated Nov 20-23, 2011, Taiwan.
    Link :http://www.icoff2011.org/SponsorSessionSpeakers.html

  • Presently, we are undertaking 12 end to end clinical trial managementing various therapeutic areas for Indian, Malaysian and Japanese based MNC.

Our Services

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Vision and Mission

Vision
To become the world’s premier quality driven organization in the field of clinical research..Readmore

News and Downloads

Article in Deccan Chronicle Chennai (04-Aug-13 Pg26) on the health benefits..Readmore

Accreditation

ISO Certificate
We have successfully completed the2nd Surveillance Audit for ISO 9001:2015Download

Corporate Brochure

No matter what the scope of the activity, our approach remains consistent. Quality Wins!..Download