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Blue Bell Consulting (BBC) is a leading full-service consulting firm in China while providing world-class professional services for FDA-regulated industries worldwide
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Latest Training Course
Time: 9/3-9/5/2008
Site: Shanghai
Instructor: W. Mel Dong, PhD
Fee: RMB 3,800/person
Course Status: Recruiting
FDA Application
DMF DMF - Raw Drug Materials and APIs
A Drug Master Files (DMF) provides confidential detailed information about facilities, processes, packaging, and storage of a RDM or API
ANDA ANDA - Generic Drugs
An Abbreviated New Drug Application (ANDA) contains data which provides for the review and ultimate approval of a generic drug product
IND IND - Investigational Drugs
An Investigational New Drug Application (IND) is a request for FDA authorization to administer an investigational drug to humans
510(k) 510(k) - Medical Devices
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective
IDE IDE - Investigational Devices
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data
Routine Consultation
BBC Training

Open Course Listing

cGMP Interpretation and Application
cGMP for BPCs and APIs
QSR for Medical Devices
cGMP: Compliance Auditing
cGMP for Sterile Drugs
cGMP: Laboratory Controls
cGMP: Batch Records Review
cGMP: Qualification and Validation
Computer System Validation and ER/ES
FDA Regulations: New/Generic Drugs
FDA Regulations: Medical Devices
Clinical Trial: Design and Analysis
FDA Compliance Consultation
GMP Compliance Consultation GLP Compliance Consultation GCP Compliance Consultation
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