In an ever-evolving Lifesciences Regulatory arena, expanding to new markets always require a thorough knowledge on regional application formats, dossier content requirements, submission procedures etc. “What Is” is a pool of such regional Regulatory prerequisites that enable organizations or manufacturers understand on-the-ground procedural requirements in detail. What Are IND (Investigational New Drug) and NDA (New Drug Application) Applications? What Are Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)? What Are Purple and Orange Books? What Are Quasi-Drugs in South Korea? What Is A Biologics License Application (BLA)? What Is A DUNS Number? What Is A Design History File (DHF)? What Is A PADER? What Is A Product Information File (PIF)? What Is Active Substance Master File (ASMF)? What Is An ICSR? What Is An SmPC? What Is Corrective Action and Preventive Action (CAPA)? What Is FDA Unified Registration and Listing System (FURLS)? What Is Post-Authorisation Safety Study (PASS)? What Is TPD (Therapeutic Product Directorate)? What Is an ESG? What Is the De Novo Classification Process? What are 351(A) & 351(K)? What are 505(b)(1) & 505(b)(2)? What are National, Mutual Recognition, Decentralized and Centralized Procedures? What are SANDS and SNDS? What are TODOKEDE, NINSHO and SHONIN? What is 21 CFR Part 11? What is 21st Century Cures Act What is A Certified Product Information Document-Chemical Entities (CPID-CE)? What is A Cosmetic Product Safety Report (CPSR)? What is A GxP? What is A Pharmacovigilance System Master File (PSMF)? What is A Private Label? What is A Reference Listed Drug (RLD)? What is AERS? What is CBER? What is CFR (Code of Federal Regulations)? What is Certification of Suitability (CEP) and Sister CEP submissions? What is CosIng? What is DailyMed? What is EU General Data Protection Regulation (EU GDPR) What is European Database on Medical Devices (EUDAMED) What is GDUFA? What is GUDID? What is INMETRO Certification? What is Medical Device Reporting (MDR)? What is Medical Device Single Audit Program (MDSAP)? What is PBRER? What is Pharmacovigilance Risk Assessment Committee (PRAC)? What is Pregnancy and Lactation Labeling Rule? What is QUEST 3+ Submission? What is Reference Safety Information (RSI)? What is Regulated Product Submission (RPS)? What is SUGAM? What is Structured Product Labeling (SPL)? What is Target Product Profile (TPP)? What is The Center for Drug Evaluation and Research (CDER)? What is Todokede? What is Trial Master File (TMF)? What is UDI? What is a Clinical Evaluation Report (CER)? What is a Drug Master File (DMF)? What is a Sunset Clause? What is an API? What is an IMPD? What is eCOSMA Registration What is eCTD? Who is A Mexican Registration Holder (MRH)? What Is A Periodic Safety Update Report (PSUR)? What Is CE Marking? What Is Identification of Medicinal Products (IDMP)?