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 are Excipients?
- What is CPNP?
- What is French Sunshine Act?
- What is SUGAM?
- What is Software as a Medical Device (SaMD)?
- What is a CTA?
- What is a Marketing Authorization Application (MAA)?
- What is a Voluntary Cosmetic Registration Program (VCRP)?
- Who Is A Marketing Authorization Holder (MAH)?
- 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)?
- What is An Australian Public Assessment Report (AusPAR)?
- What is New Chemical Entity (NCE)?
- What is the Office of Generic Drugs (OGD)?