Maira Lifesciences Private Limited

Your go-to business partner for ease and guidance in navigating the complex landscape of Compliance and Regulatory Affairs in India. Partnering with us ensures around-the-clock support, practical guidance and comprehensive technical assistance from the start of the project’s journey

Our Expertise

Form 11 & 12
CT 16 & 17

Test licenses to import

CT 10 & 11
CT 12 & 14
CT 13 & 15
Form 29 & 30

Test Licenses to Manufacture

Form 8 & 10

Import for Commercialization

Form 19, 20B, 21B

Wholesale Licenses

Form 40 & 41

Registration for Import

CT 04 & 06

To Conduct Clinical Trial

CT 05 & 07

To Conduct BA/BE studies

CT 08 & 09

Registration of BA/BE Centre

CT 18 & 19, 20

Import New Drug for Sale

CT 21 & 22, 23

Manufacture for Sale of New Drug

CT 01 & 02, 03

Registration of Ethics Committee

Form 24 & 25/24A & 25A Form 27 & 28/27A & 28A

Manufacturing Licenses (Own/Loan)

We work with

  • CDSCO Delhi
  • Zonal CDSCO
  • State FDAs
  • Border Customs
  • Department of Biotechnology
  • RCGM
  • CBN
  • NCB
  • Regional & Central Laboratories
  • IPC

Product Categories:

  • Bulk Drug
  • Finished Dosage Forms
  • Medical Devices
  • Cosmetics
  • Ayurveda
  • Biologics

Our Main Services

Facility Plan Approvals

  • Layout review
  • Document review
  • Pre-audit of facility
  • Submission & presentation
  • Response to Query

Certifications

  • Schedule M/WHO GMP inspections
  • Written Certification
  • ISO Certifications
  • R&D DSIR Recognition
  • Certificate of Pharmaceutical Products (COPPs)
  • Free sale certificate (FSC)
  • Performance Certificate

Commercial Manufacturing Licenses

  • Manufacturing Licenses
  • Repackaging
  • License for notified Medical Devices & Critical Diagnostics manufacturing units, blood banks, Vaccine, Sera, LVP
  • Additional section/category approval in existing License
  • Technical Persons Approval
  • Wholesale licenses
  • Loan Licenses

Approvals

  • New/ Subsequent Drug Formulations
  • New/ Subsequent Bulk Drug
  • New/ Subsequent Fixed Dose Combinations (FDCs)
  • Import registration of Medical Devises & Diagnostics
  • Import registration of Cosmetic products
  • BE NOC for Export purpose
  • Export NOC of banned drugs
  • Registration of Ethics Committee
  • Approval of BA-BE Center
  • Global and local Clinical Trial Approval
  • Export Import Permits