Pharmaceutical Questionnaire Pharma CTD Assessment Step 1 of 5 20% 1- What is the product type?(Required) Generic Drug (small molecule) Branded / Originator Product Biologic / Biosimilar Herbal / Traditional Medicine Over-the-Counter (OTC) Product 2- What is the primary dosage form?(Required) Solid Oral (tablets, capsules, sachets) Liquid Oral (syrups, suspensions) Parenteral / Injectable Topical / Transdermal Other (inhaled, ophthalmic, etc.) 3- Which regulatory authority are you submitting to? (select all that apply)(Required) NAFDAC (Nigeria) EAC / Kenya PPB / TFDA (East Africa) SAHPRA (South Africa) WHO Prequalification Other / Multiple African Markets 4- What type of dossier submission is this?(Required) Full CTD Dossier (new application) Abridged / Abbreviated Dossier Variation / Post-Approval Change Renewal / Re-registration Not sure yet Module 1- Administrative & Regional Documents(Required) Complete - all documents compiled and reviewed In Progress - partially compiled Not Started Not Applicable Module 2 - Overviews & Summaries(Required) Complete In Progress Not Started Not Applicable Module 3 - Quality (CMC)(Required) Complete In Progress Not Started Not Applicable Module 4 - Nonclinical Study Reports(Required) Complete In Progress Not Started Not Applicable / Waived Module 5 - Clinical Study Reports(Required) Complete In Progress Not Started Not Applicable / Waived Do you have a current GMP certificate for your manufacturing site?(Required) Yes - valid and current Yes - expiring within 12 months No - not yet obtained Not sure Do you have completed stability data for the target market climate zone?(Required) Yes - full long-term and accelerated data available Partial - accelerated data only, long-term ongoing No - studies not yet initiated Not sure What is your estimated timeline to submission?(Required) Under 3 months 3-6 months 6-12 months More than 12 months / exploring options Full Name *(Required)Email Address(Required) Company / Organisation(Required)Country(Required)NigeriaKenyaGhanaSouth AfricaTanzaniaEthiopiaUgandaRwandaZambiaZimbabweCôte d'IvoireSenegalOther African countryOutside AfricaJob Title / Role(Required)