Regulatory Intelligence Terms (86)

FDA regulations governing electronic records and electronic signatures to ensure their trustworthiness and reliability.

505b1 supports cross-functional regulatory execution across quality, clinical, and safety teams.

505b2 helps teams standardize terminology and improve decision traceability.

505J helps teams standardize terminology and improve decision traceability.

Aggregate Reporting is a recurring concept across regulatory planning, compliance operations, and global submissions.

ANDS helps teams standardize terminology and improve decision traceability.

ANNEX 11 supports cross-functional regulatory execution across quality, clinical, and safety teams.

Bioequivalence helps teams standardize terminology and improve decision traceability.

Biosimilar is a recurring concept across regulatory planning, compliance operations, and global submissions.

Bridging STUDY supports cross-functional regulatory execution across quality, clinical, and safety teams.

Causality Assessment supports cross-functional regulatory execution across quality, clinical, and safety teams.

CDMO helps teams standardize terminology and improve decision traceability.

Centralized Procedure is a recurring concept across regulatory planning, compliance operations, and global submissions.

CHANGE Control supports cross-functional regulatory execution across quality, clinical, and safety teams.

CHMP supports cross-functional regulatory execution across quality, clinical, and safety teams.

CLASS II is a recurring concept across regulatory planning, compliance operations, and global submissions.

CLASS III is a recurring concept across regulatory planning, compliance operations, and global submissions.

Combination Product supports cross-functional regulatory execution across quality, clinical, and safety teams.

Companion Diagnostic is a recurring concept across regulatory planning, compliance operations, and global submissions.

Container Closure SYSTEM is a recurring concept across regulatory planning, compliance operations, and global submissions.

Continued Process Verification supports cross-functional regulatory execution across quality, clinical, and safety teams.

Control Strategy helps teams standardize terminology and improve decision traceability.

Critical Process Parameter supports cross-functional regulatory execution across quality, clinical, and safety teams.

CSV helps teams standardize terminology and improve decision traceability.

The completeness, consistency, and accuracy of data throughout its lifecycle, following ALCOA+ principles.

Deficiency LETTER supports cross-functional regulatory execution across quality, clinical, and safety teams.

Disproportionality helps teams standardize terminology and improve decision traceability.

DRUG Product helps teams standardize terminology and improve decision traceability.

DRUG Substance helps teams standardize terminology and improve decision traceability.

E6 GCP is a recurring concept across regulatory planning, compliance operations, and global submissions.

Electronic DATA Capture supports cross-functional regulatory execution across quality, clinical, and safety teams.

Electronic Signature is a recurring concept across regulatory planning, compliance operations, and global submissions.

ETASU is a recurring concept across regulatory planning, compliance operations, and global submissions.

The European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines.

Expanded ACCESS helps teams standardize terminology and improve decision traceability.

Expedited Reporting supports cross-functional regulatory execution across quality, clinical, and safety teams.

Extractables AND Leachables is a recurring concept across regulatory planning, compliance operations, and global submissions.

FIELD ALERT REPORT supports cross-functional regulatory execution across quality, clinical, and safety teams.

The US federal agency responsible for protecting public health by regulating food, drugs, biologics, medical devices, and cosmetics.

FORM 483 is a recurring concept across regulatory planning, compliance operations, and global submissions.

GLP helps teams standardize terminology and improve decision traceability.

GOOD Documentation Practices supports cross-functional regulatory execution across quality, clinical, and safety teams.

GXP helps teams standardize terminology and improve decision traceability.

Canada's federal department responsible for regulating drugs, medical devices, and other health products.

HPFB helps teams standardize terminology and improve decision traceability.

ICH Q10 is a recurring concept across regulatory planning, compliance operations, and global submissions.

ICH Q1a supports cross-functional regulatory execution across quality, clinical, and safety teams.

ICH Q8 helps teams standardize terminology and improve decision traceability.

ICH Q9 is a recurring concept across regulatory planning, compliance operations, and global submissions.

IDE is a recurring concept across regulatory planning, compliance operations, and global submissions.

IMPORT ALERT supports cross-functional regulatory execution across quality, clinical, and safety teams.

A global organization that develops harmonized pharmaceutical guidelines to ensure drug quality, safety, and efficacy.

Investigator Brochure helps teams standardize terminology and improve decision traceability.

ISO 13485 supports cross-functional regulatory execution across quality, clinical, and safety teams.

All written, printed, or graphic matter on or accompanying a drug or device, including the package insert and promotional materials.

MAA is a recurring concept across regulatory planning, compliance operations, and global submissions.

MARKET Exclusivity supports cross-functional regulatory execution across quality, clinical, and safety teams.

MEDDRA helps teams standardize terminology and improve decision traceability.

Medication GUIDE helps teams standardize terminology and improve decision traceability.

NDS supports cross-functional regulatory execution across quality, clinical, and safety teams.

ORANGE BOOK is a recurring concept across regulatory planning, compliance operations, and global submissions.

Paragraph IV helps teams standardize terminology and improve decision traceability.

21 CFR Part 210 provides general CGMP requirements for manufacturing, processing, packing, and holding of drug products.

21 CFR Part 211 specifies current good manufacturing practice requirements for finished pharmaceuticals.

21 CFR Part 312 governs Investigational New Drug applications and clinical study conduct for investigational drugs in the US.

21 CFR Part 314 defines submission and approval requirements for NDAs and ANDAs in the United States.

PART 600 supports cross-functional regulatory execution across quality, clinical, and safety teams.

PART 820 helps teams standardize terminology and improve decision traceability.

Japan's regulatory agency responsible for approving pharmaceuticals, medical devices, and regenerative products.

POST MARKET Surveillance supports cross-functional regulatory execution across quality, clinical, and safety teams.

Predicate helps teams standardize terminology and improve decision traceability.

QOS is a recurring concept across regulatory planning, compliance operations, and global submissions.

Randomization helps teams standardize terminology and improve decision traceability.

REAL WORLD DATA is a recurring concept across regulatory planning, compliance operations, and global submissions.

REAL WORLD Evidence is a recurring concept across regulatory planning, compliance operations, and global submissions.

RLD supports cross-functional regulatory execution across quality, clinical, and safety teams.

ROOT CAUSE Analysis helps teams standardize terminology and improve decision traceability.

SHELF LIFE supports cross-functional regulatory execution across quality, clinical, and safety teams.

SOURCE DATA Verification supports cross-functional regulatory execution across quality, clinical, and safety teams.

Special Controls helps teams standardize terminology and improve decision traceability.

Substantial Equivalence supports cross-functional regulatory execution across quality, clinical, and safety teams.

Technical FILE helps teams standardize terminology and improve decision traceability.

Technology Transfer helps teams standardize terminology and improve decision traceability.

Australia's regulatory agency for therapeutic goods including prescription medicines, medical devices, and biologicals.

An official FDA notice of significant regulatory violations requiring prompt corrective action.

Whodrug supports cross-functional regulatory execution across quality, clinical, and safety teams.