Demystifying the complex terminology of drug development, regulatory standards, and biopharma operations.
A Contract Development and Manufacturing Organization (CDMO) specializes in drug development and manufacturing. CDMOs provide services that range from drug discovery and pre-clinical stages to full-scale commercial manufacturing.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
An Abbreviated New Drug Application (ANDA) is an application for a generic drug approval for an existing licensed medication or approved drug.
An Active Pharmaceutical Ingredient (API) is the part of any drug that produces its effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways.
Modality refers to the way in which a drug or medical treatment acts. Common modalities include small molecules, monoclonal antibodies (mAbs), cell and gene therapies, and mRNA.
The Common Technical Document (CTD) is a set of specifications for a registration application that will be accepted by regulatory authorities in relevant countries.
A Contract Research Organization (CRO) provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
Clinical trial phases are the stages in which scientists conduct experiments with a health intervention in an attempt to learn about its effects, safety, and effectiveness.
A Contract Manufacturing Organization (CMO) manufactures pharmaceutical products to a sponsor's existing, validated process. Unlike a CDMO, a CMO typically provides manufacturing capacity rather than process development.
An FDA Form 483 is issued by an investigator at the end of an inspection to list observed conditions that may violate the Food, Drug, and Cosmetic Act. It is a list of observations, not a final determination of non-compliance.
An FDA Warning Letter is a formal escalation issued when a firm's response to earlier observations is inadequate or when violations are significant. An open Warning Letter against a manufacturing site is a serious sourcing risk.
A drug recall is the removal or correction of a marketed product. The FDA classifies recalls as Class I (reasonable probability of serious harm), Class II (temporary or reversible harm), or Class III (unlikely to cause harm).
A Drug Master File (DMF) is a confidential submission to a regulatory authority containing detailed information about facilities, processes, or articles used in the manufacturing of drugs. API suppliers often hold a DMF and grant a Letter of Authorization to sponsors.
Technology transfer is the process of moving a manufacturing process, analytical methods, and knowledge from one party or site to another — for example, from a sponsor to a CDMO, or between manufacturing scales.
A Request for Information (RFI) is a structured questionnaire sent to candidate suppliers to gather comparable data on capabilities, capacity, quality systems, and compliance before deeper diligence.
Fill-finish is the final stage of drug product manufacturing, where the formulated drug is filled into its final container (vial, syringe, or cartridge), sealed, and packaged under sterile conditions.
An Antibody-Drug Conjugate (ADC) is a targeted therapy that links a monoclonal antibody to a cytotoxic drug, allowing the payload to be delivered selectively to specific cells, most commonly in oncology.
Bioequivalence means two drug products release their active ingredient into the bloodstream at the same rate and extent. Demonstrating bioequivalence is central to generic drug approval.
An excipient is an inactive substance formulated alongside the active pharmaceutical ingredient — such as binders, fillers, preservatives, or stabilizers — that aids manufacturing, delivery, or stability.
A New Drug Application (NDA) is the formal request to the FDA to approve a new pharmaceutical for sale and marketing in the United States, containing all preclinical, clinical, and manufacturing data.
A Biologics License Application (BLA) is the request to the FDA to market a biologic product. It is the biologics equivalent of an NDA and includes manufacturing and quality data specific to biologics.
Dual sourcing is the practice of qualifying two or more suppliers for a critical material or service to reduce concentration risk and protect against single-point supply failures.
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