Publishing Services

We have in-house facility to publish and submit the electronic and paper-based regulatory submissions to the Regulatory Authorities. We provide full submission lifecycle support of the product through our elite publishing software system. Also, the in-built validator ensures that the published regulatory submissions are in compliance with the Regulatory Authority's standards. We can assist you in the electronic submission of the following regulatory documents, but not limited to:

  • Electronic submission of INDA, NDA, BLA, ANDA, DMF, Amendment, Supplementary report [Changes Being Effected (CBE), CBE30, Prior Approval Supplement (PAS)] and Annual report;
  • Electronic submission of MAA, Hybrid application, Generic application, Biosimilar application, Variation filing (Type IA, IAIN, IB, II), ASMF and CEP;
  • New/renewal marketing authorisation and variation/ supplement filing of the TGA (Therapeutic Goods Administration) submission, Therapeutic Products Directorate (TPD) submission, Gulf Cooperation Council (GCC) submission, Swissmedic submission and Medicines Control Council (MCC) submission;
  • Structured Product Labelling (SPL), Orphan Drug Designation Request, Clinical Study Report (CSR), Investigator Brochure (IB), Clinical Protocol and Case Report Form;
  • PBRER and PADER submission.

Our members of the publishing department are skilled professionals of the publishing arena. They are also well trained with most recently updated software such as Microsoft Word, Adobe Acrobat Professional, AutopageX Adobe plug-in, CoreDossier, ISIToolBox Pharma Edition, ISIWriter templates and ISIPublisher. As we deal mostly with regulated markets, therefore work executed by us readily meets quality and standard of international norms.