Regulatory Terms Starting With C

Causality Assessment

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

CDMO (CDMO)

CDMO helps teams standardize terminology and improve decision traceability.

Center for Biologics Evaluation and Research (CBER)

CBER is the FDA center responsible for regulating vaccines, blood products, and certain cellular and gene therapy products.

Center for Devices and Radiological Health (CDRH)

CDRH is the FDA center that regulates medical devices and radiation-emitting electronic products in the United States.

Center for Drug Evaluation and Research (CDER)

CDER is the FDA center responsible for evaluating and regulating prescription and over-the-counter human drugs in the United States.

Centralized Procedure

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

CGMP (CGMP)

CGMP is foundational for process control, product quality, and inspection-readiness in manufacturing.

CHANGE Control

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

Chemistry, Manufacturing, and Controls (CMC)

The section of a regulatory submission describing a drug's composition, manufacturing process, and quality controls.

CHMP (CHMP)

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

CIOMS (CIOMS)

CIOMS guides risk surveillance, reporting discipline, and benefit-risk decision updates.

CLASS II

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

CLASS III

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

Cleaning Validation

Cleaning Validation is foundational for process control, product quality, and inspection-readiness in manufacturing.

Clinical Evaluation REPORT

Clinical Evaluation REPORT supports compliant clinical development and cleaner decision-making across trial phases.

Clinical HOLD

Clinical HOLD is central to trial design quality, protocol execution, and evidence credibility.

Clinical STUDY REPORT

Clinical STUDY REPORT helps teams align study conduct, data integrity, and regulator expectations.

Clinical TRIAL

Clinical TRIAL supports compliant clinical development and cleaner decision-making across trial phases.

Combination Product

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

Common Technical Document (CTD)

An internationally harmonized format for organizing pharmaceutical regulatory submissions into five standardized modules.

Companion Diagnostic

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

Comparability Protocol

Comparability Protocol is central to trial design quality, protocol execution, and evidence credibility.

Complete Response Letter (CRL)

An FDA letter indicating that an application review is complete but the application is not approved as submitted.

Confirmatory TRIAL

Confirmatory TRIAL is central to trial design quality, protocol execution, and evidence credibility.

Consent DECREE

Consent DECREE is central to trial design quality, protocol execution, and evidence credibility.

Container Closure SYSTEM

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

Continued Process Verification

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

Contract Research Organization (CRO)

A company that provides outsourced research services to pharmaceutical and biotechnology companies.

Control Strategy

Control Strategy helps teams standardize terminology and improve decision traceability.

Corrective and Preventive Action (CAPA)

A systematic approach to identifying, investigating, and addressing the root causes of quality problems.

CPV (CPV)

CPV guides risk surveillance, reporting discipline, and benefit-risk decision updates.

CQA (CQA)

CQA is foundational for process control, product quality, and inspection-readiness in manufacturing.

Critical Process Parameter

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

Critical Quality Attribute

Critical Quality Attribute is used to prevent quality failures and strengthen manufacturing control strategy.

CSV (CSV)

CSV helps teams standardize terminology and improve decision traceability.