Regulatory Support

Liveon Biolabs provide single point Consultancy Services for your Pharmaceutical Regulatory and Project Management resource, servicing the ever growing requirements of the Pharmaceutical Generic Industry. We offer an efficient and reliable regulatory and quality support, focused especially from the perspective of international requirements. We always aspire to provide an efficient and value added support in obtaining faster Regulatory approvals for our clients.

We provide a creative, flexible, dedicated and reliable regulatory and quality centric customer focused pharmaceutical services. We also provide regulatory affairs support as consultants to pharmaceutical companies based across the globe on timely registration of their products globally.

Liveon also provides efficient solutions to making good submissions using available data and Documents.

DMF/ASMF

Drug master file (DMF) or Active substance master file (ASMF) is the set of series of information for an Active Pharmaceutical Ingredient (API) or Drug substance brought together in CTD format as per regulatory requirements. DMF provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Liveon Biolabs provides efficient technical writing and submission of DMF/ASMF for our clients globally. All documents and data required for the DMF submissions are evaluated and aligned as per the international requirements and guidance. We provide customized service for advice and complete project management.

We provide our professional services but not limited to the following activities:

  • Review with providing solutions for all the technical documents for API.
  • Guidance for developing documents and conducting studies as per regulatory requirements for global market.
  • Writing and compiling DMF/ASMF as per CTD for US, EU, Australia, Canada, ROW etc.
  • Submission of DMF/ASMF as per, eCTD, CTD in PDF or Paper format.
  • Writing quality overall summary (QOS) as per CTD.
  • Gap analysis of existing DMF/ASMF
  • Query response assistance.
  • Assistance in query reply to all the agencies and different procedures in EU
  • Preparation and submission of variation document in relation to API to assist sponsor for submitting their variation.
  • Assistance with various formats and Templates of letters required to be submitted to agencies like Cover letter, LOA, Debarment certificate, commitment letters etc…

EU Marketing Authorization

European countries comprising of 31 nations have their own national requirements, fees requirements, different language and many others, making the regulatory filings very complex.

Liveon Biolabs will help you sail through complex requirements with ease. We can help with following activities to write file and get approval marketing authorization applications (MAA) :

  • Guidance in best procedure to adopt for filing a MAA
  • Dossier writing for MAA as per ICH in eCTD.
  • Submission MAA to European countries as per the schedule via National, MRP DCP and CP.
  • Conversion of CTD or NeeS format to eCTD
  • Summary writing for Module 2 :
    • Quality overall summary
    • Non-clinical overview (Module 2.4) and summaries (Module 2.6)
    • Clinical overview (Module 2.5) and summaries (Module 2.7)
  • Literature references for Module 4 and Module 5
  • Assistance in Assessment report interpretation and response for the same at various steps during the national, MRP and DCP.
  • SmPC: Preparation of harmonized summary of product characteristics
  • PIL: Preparation of Patient information leaflet with its mock ups. Coordinating for its readability testing as per EFPIA General Recommendations for Readability User Testing of Package Leaflets for Medicinal Products for Human Use and MHRA Guidance on the user testing of Patient Information Leaflets.
  • PSUR Writing

ROW and ASEAN Market

Liveon Biolabs provides complete service in writing, compiling and submission of ACTD and country specific dossier for ROW (rest of the world) market.

Dossier writing for Asia, Middle East, North Africa, and Greater Arabia, Central America and the Caribbean, South America, Sub-Saharan Africa, Australia and Oceania, European countries not part of European Union as per their country specific formats.

  • Dossier writing in CTD format as per countries requirement
  • Gap analysis and Conversion of Country specific dossier to CTD format
  • Dossier writing as per ASEAN CTD Guidelines for submission of ASEAN countries from Part I to IV
  • Summary writing for Part II, III, IV
    • Quality overall summary
    • Non-clinical overview (Module 2.4) and summaries (Module 2.6)
    • Clinical overview (Module 2.5) and summaries (Module 2.7)
  • Gap analysis and solutions for finalizing the Application
  • PSUR Writing
  • Query response assistance
  • Preparation of SmPC and PIL

INDIA- DCGI Submission

  • Preclinical & Clinical Development Plans
  • Investigator Brochures
  • Product Executive Summary for SEC (subject expert committee) members
  • Dossier Preparation (For all kind of submissions)