Product Lifecycle Management

Product Lifecycle Management

  • Line extension application for change in dosage forms, indication or other applicable changes to respective health authority.
  • Product variation application – Defining the type of variation (Type I or Type II for EU, PAS, CBE 30 or APR for USA and other markets), reviewing technical data, preparation of application and submission to respective health authority.
  • CBE and PAS to USFDA – Changes Being Effected Major, Moderate (CBE 30 and CBE 0 supplements) and Minor changes, Prior approval supplements (PAS) submission to USFDA
  • Product Renewal or Re-registration – Suggesting/filing for renewal / re-registration application, well in advance to avoid de-listing of product registration.
  • Annual maintenance of registration to hold product license and registration.
  • Annual Product Review submission – Preparation and submission of Annual Product Review to health authority
  • Pharmacovigilance compliance support.
  • Review of technical data and further submission in reference to fulfillment of commitment to conditional approvals (CAs).