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Regulatory Services
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Regulatory Services (ANDAs)

Regulatory Affairs

Piramal Corporate Regulatory Affairs, located in Mumbai, India provides expert clinical & regulatory support in all phases of global drug development programs. This includes regulatory support of New Chemical Entity’s development (NCE), Clinical Trials, Marketing products, Generics, OTC products & Medical devices

Below mentioned are detailed features of our services that we offer to different type of customers

Finished Formulations

  • Filing of NDA / ANDAs in USA, MAs in Europe, Canada, Asia Pacific and Semi-regulated countries.
  • Experience in regulatory filing of dosage forms including Immediate / Modified released solid dosage forms, parenterals (liquid, powder for injection), Nasal spray etc.
  • ANDA / Generic Application with Paragraph I, II, III and IV certifications
  • Experience in of filing ‘First to File’ generic applications
  • Experience in of filing 505 (b) (2) application in the US
  • Support Innovator Companies to writing sNDA / NDA’s (CMC Section-Module 1, 2 &3)
  • Experience of review and compilation of Toxicology, Pharmacology and Clinical Sections (Module 4 &5)
  • CTD / eCTD submissions with MRPs & DCP procedures in Europe.
  • Post approval maintenance – submission of PAS, CBE 30/CBE, Annual Reports to US, Vairations to EU.
  • Electronic Site registrations, GDUFA obligations like site identifications, Drug listing and SPL support for labeling for US.
  • Vitamin dossiers supporting to food industry including food facility registration to US

IND / Clinical Trial Application

  • IND expertise in compilation of CMC, pre-clinical and clinical review including regulatory development strategy.
  • IND filing experience in US, Europe (France, Hungary, Czech, Netherlands), Australia, New Zealand, Argentina and India
  • Total INDs filed by Piramal-38 No’s
    • Phase I-19 No’s,
    • Phase II-15 No’s,
    • Phase III-3 No’s
    • Phase IV-1 No.
  • CTA (in Phase I and Phase II and III) filed in various countries in Europe, Canada, US and India.
  • Three Herbal products are in phase-II / III clinical trial
  • For clients (INDs filed by client) – JV with clients complete IND filing for co-development
    • Phase I- 5 No’s
    • Phase II- 2 No’s

Active Pharmaceutical Ingredients

  • Experienced in filing DMFs, ASMFs and CEP’s / COS
  • About 40 DMF’s and COS submitted in USA and Europe for supplying APIs to regulated markets
  • Active DMFS in USA, Europe, Canada, Asia Pacific and semi-regulated countries (as applicable).
  • CTD/eCTD submissions successfully done for EU,US, ROW countries.