wisdomhealthcare

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  • bharat.narnavar@wisdomhealthcare.co.in

Wisdom Healthcare Solutions

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CDSCO is India’s central drug authority, having the primary responsibility of enforcing the Drugs and Cosmetics Act 1940 and Rules 1945. It has offices throughout India and a decentralized organizational structure, collaborating with the Drugs Controller General of India. Zonal level operations are critical to the overall functioning of the authority across India.
Wisdom Healthcare Solutions have emerged as India’s foremost authority in CDSCO compliance. We specialize in ensuring flawless CDSCO compliance and are the trusted choice for over 100 companies.
We assists manufacturers in overcoming obstacles by creating clear and concise dossiers and robust regulatory strategies for the submission of applications for the approval of different drug products

Drug

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Medical Devices

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Cosmetics

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Biological Molecules

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Drug

Investigational New Drug, New Drug & Subsequent New Drug Applications.
Preparation of presentation for SEC (Subject Expert Committee) Meeting on the behalf of Sponsors.
Obtaining BENOC for Complex / Critical molecules including expedition activities.
Written Confirmation.
Application for grant of permission to import new drug for sale or distribution
BENOC for Export Applications and Clinical Trial Applications (Phase II- IV) on SUGAM Portal.
Import and registration of New Molecule application for API/formulation.
Registration of Blood Bank on SUGAM Portal to file online applications.
Application for import of RLD/ API for test examination and analysis purpose.
Application for manufacture of new drug for test examination and analysis purpose.
Registration of firm on NSWS portal

Medical Devices

  • Application of Manufacturing of MD/IVDs for Class C and Class D.
  • Application of import of MD/IVDs for Sale and Distribution.
  • Application of import of MD/IVDs for Testing purpose
  • Application to manufacture of MD/IVDs for Testing Purpose.
  • Application of Registration of Laboratories for Carrying out Medical Device Test on behalf of Manufacturers.
  • Application of Manufacturing of Medical Devices for Class C and Class D for Loan License.
  • Volunteer registration of non-sterile and non-measuring Class-A medical devices.

Cosmetics

Import registration certificate to be issued for import of cosmetics into India (Form Cos-02)
Permission to import or manufacture new cosmetics in India (Form Cos-03)
Loan license to manufacture cosmetics for sale or for distribution (Form Cos-09)
Approval for carrying out tests on cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of cosmetics (Form Cos-23)
Form in which the inspection book shall be maintained (Form COS-11)
Import Registration Number to be issued for import of already registered cosmetics into India (Form COS-4A)
License to manufacture cosmetics for sale or for distribution (Form COS-8)
Application for grant of permission for new cosmetics for obtaining import registration certificate or manufacturing license (Form COS-12).

Biological Molecules

  • BENOC for Export Applications and Clinical Trial Applications (Phase II- IV) on SUGAM Portal for Biological Molecules.
  • Import/ export applications for biological purpose for test analysis purpose.
  • Form 29 NOC (CT-11) and Plan layout approval for biological products.