REGISTRATION

Consulting and Regulatory Services

Over the years, we have undertaken several registration. Working closely, we have a strong understanding of the requirements and process in India for NOC, clinical trials and other conditions required to ensure a successful entry into India with the correct licenses & requirements.

A & C PharmaSpecialities is a Mumbai based independent consulting professional company run by experts who specialize in providing consulting services on all DCGI related issues. We provide regulatory services to the Indian & international pharmaceutical industry for.

We provide the following services for Registration:

1) Consultancy on end to end registration. Filing on behalf of our principles.

2) Consultancy on end to end registration and marketing, working as an extended arm of our principles for the Indian and other markets.

We Specialize in helping our customers
to obtain the following:

  • Drugs Registration (Form 41)
  • Vaccines Registration (Form 41)
  • Medical Devices Registration (Form 41)
  • Cosmetics Registration (Form 43)
  • Information Regarding any types of Queries under Drug Rules & Custom Rules.
  • Test License (Form 11)
  • New Drug Permission (Form 45)
  • Hospital License (Form 12AA)
  • Blood Bank and Blood Product Registration
  • NOC for Import of Half finished or Raw materials.
  • Loan License
  • Legalization of Export/Import documents
  • Neutral Code License
  • Import License (Form 10)
  • Any other Organizational Clearances say Animal Husbandry, Diary Products Etc

API Registration

Requirement :
Dossier as per DCGI Guidelines.

Time Taken :
8 to 12 months

Category Fee

$10000
Factory Registration

$5000 per product
Product Registration

$25000
Factory Inspection

$3500
New Drug Application

SCOPE OF THE WORK

  • Assisting the preparation of dossier & application
  • Getting TR Challan.
  • Review of Dossier
  • Submission of dossier at DCGI, Delhi
  • Updating while testing of drugs at CDTL
  • Query Replies from DCGI
  • Continuous follow-up
  • Maintain Confidentiality & Anti-corruption Laws
  • Regular updating

Registration

precila@acpharms.com

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