Our expertise in India

Regulatory Affairs Services:

  • Regulatory Strategy and planning for initial as well as post approval submissions for Europe, US, Canada and Australia.
  • Management and support with scientific advice meetings with EU agencies regarding product development and/or MAA submission.
  • Controlled correspondence and Pre-submission meetings for US.
  • Management and Preparation of all types of Regulatory Submissions throughout the product life cycle for Europe, US, Canada and Australia.
  • IMPD-Quality dossier preparation for Clinical trial application to EU
  • CPP application to EU agencies in support of product export to other countries
  • Preparation and review of mock-ups


Initial submissions:

  • Due diligence or technical gap analysis of old dossiers/dossiers of other market to extend the submission in Europe, US, Canada and Australia.
  • Dossier CMC module writing and compilation for Europe, US, Canada and Australia.
  • Module 1 preparation for all type of submissions for Europe, US, Canada and Australia.
  • Product information preparation – i.e Europe-SmPC, Labelling, PIL, US-Pack insert, Medication guide, Labelling, SPL, Canada- Product Monograph, Labelling, Australia-Product information, Package insert, CMI.
  • Preparation of Module 1.7.1 Orphan similarity report for Europe submissions
  • National phase package preparation for Europe submissions
  • Review of Elemental & Nitrosamine impurity risk assessment reports
  • NDC labeler code request for US
  • Drug Establishment License application for Canada


Drug substance submissions

  • ASMF/CEP/US DMF/Canada MF dossier writing and compilation


Life Cycle Management


  • Variations (major, minor, separate, groupings)
  • Renewal
  • Market authorization transfer
  • Cancellation of marketing authorization
  • Submission of labelling changes applications
  • Sunset clause exemption applications
  • Hands-on support and troubleshooting of any issues throughout the approval process


  • Post approval changes (PAS, CBE, Annual reports, amendments)
  • Market authorization transfer
  • Field Alert Reports
  • Establishment registration
  • Facility self-identification


  • Post approval changes (Supplements, Annual reports)
  • Market authorization transfer


  • Post approval changes (Correction to ARTG entry, Notifications, Self-assessable requests (SARs), Category-3 variations)
  • Transfer of sponsorship


Document and Submission Publishing

  • Legacy document conversions, submission readiness of pdf documents to eCTD standards, and compliance with regulatory and customer-specific standards
  • Global eCTD dossier compilation, validation, and publishing


Medical team:

  • Preparation of non-clinical and clinical modules and respond to regulatory queries
  • Review of clinical study documents
  • Preparation of IB
  • Bioanalytical audits and audits of clinical trial sites
  • Preparation of non-clinical and clinical strategy documents
  • Preparation of briefing package for regulatory meeting
  • Preparation of medical justification
  • Provision of medical and safety expert in clinical trials.


Pharmacovigilance activities:

  • Case Management [Downloading, Triaging, Data Entry, Medical Review, Quality Check, Archival / Submission (EMA/USFDA)]
  • Signal Management
  • Preparation and Review of Risk Management Plan (RMP)
  • Preparation and Review of Periodic safety update reports (PSUR) / Periodic Benefit-risk Evaluation Reports (PBRER)
  • Preparation and Review of Periodic Adverse Drug Experience Report (PADER)
  • Preparation and Review of Addendum Clinical Overview (ACO)
  • Literature Monitoring (through Pubmed)
  • Local Literature Monitoring
  • Regulatory Monitoring (EMA / MHRA)
  • Management of Extended EudraVigilance Medicinal Product Dictionary is a database (xEVMPD database)
  • Provide support in audit / inspection

Facts & Figures


Birth of our Indian team (as ELC Group) currently supporting global clients with end-to-end CMC, regulatory affairs, regulatory operations, clinical, non-clinical and PV projects; acquired by ProductLife Group in 2021


Hands-on, delivery-oriented technical experts and operational staff.


Clients throughout the United States, Europe, and the rest of the world

Where to find us


Momaja Life Sciences India Private Limited.,

304 & 305, Sarthik Square, 3rd Floor,

Near. GNFC Info Tower, S.G.Road, Ahmedabad-380054