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).