FDA Registered Manufacturers

FDA Registered Manufacturers www.acggp.com

FDA Registration is Establishments facilities that manufacture, label, package, or perform certain otheroperationsonfoods,drugs,medicaldevices are required to registerwithFDA. A&C provides the FDA registeredmanufacturing services in theUS.

The drug approval process takesplace within a framework thatincludes: • Analysis ofthe target condition and availabletreatments • Assessmentofbenefitsandrisks from clinicaldata. • Strategies for managingrisks.

Analysis of the targetcondition and availabletreatments FDA analyzes the condition or illness for which the drug is intended and estimates the current treatment landscape which providesthecontextforweighingthedrug’s risks and benefits. which provide thefactors for weighing the drug’srisks and benefits.

Assessment of benefits andrisks from clinicaldata FDA evaluates clinical benefits and risk information submitted by the drugmaker, taking into account any precariousness that may result from defective or incompletedata.

Strategies for managingrisks The risk management strategiesincluded an FDA-approved drug label, which clearly describes the drug’s benefits and risks. In case, a drug maker may need to apply a Risk Management and Mitigation Strategy.

ContactUs www.acggp.com info@acggp.com 9193902425

FDA Registered Manufacturers

FDA Registered Manufacturers

Presentation Transcript

FDA

FDA

FDA Summary

FDA

fda

FDA Updates

FDA

FDA Workshop

FDA LABELING

the FDA

FDA

Crossing the Threshold ( FDA Regulatory Requirements for Medical Device Manufacturers)

fda

FDA Update

fda

FDA Recalls

FDA Presentation

Registered Nurse

FDA Consultants

PharmaTech LLC Is an FDA-Registered and DEA-Licensed CDMO

Peter’s Technology - FDA REGISTERED and CFDA CERTIFIED

FDA Common Architecture Whitepaper (FDA-08)