cGMP Manufacturing CONTACT US | EVENTS | HOME cGMP Manufacturing What is cGMP? Good Manufacturing Practices (GMPs) are regulations that apply to the methods, equipment, facilities... the United States, GMPs relating to pharmaceutical forumlation is referred to as Current Good Manufacturing Practices (cGMP). United States cGMP regulations are promulgated by the United... their individual pharmaceutical related tasks. If the documentation showing how a product was made and tested is not correct, the product will not meet the required cGMP manufacturing...

in formulation development, cGMP manufacturing of clinical trial materials and consulting related to the drug development process. Our site offers information about cGMP manufacturing..., dosage form development, drug development analysis, and more. COMPANY PRECLINICAL DEVELOPMENT cGMP MANUFACTURING History Management Why IriSys? Blog Analytical Chemistry Preformulation... Development Formulation Development Compounds Development Lots Regulatory Affairs Phase I and II Quality Assurance Quality Control Formal Stability Studies cGMP Manufacturing...

cGMP Manufacturing Facility CONTACT US | EVENTS | HOME IriSys facility consists of 10,000 SF regulated by Standard Operating Procedures and current Good Manufacturing Practices.... Three cGMP manufacturing suites accommodate lot sizes appropriate for Phase I and Phase II clinical trials. IriSys maintains a California Drug Manufacturers License. Company... | Preclinical Development | cGMP Manufacturing | Platform Technologies | Regulatory Affairs Blog |Contact Us | Events | Site Map | Copyright | Privacy | Home 8810 Rehco Road, Suite F, San...

Quality Assurance CONTACT US | EVENTS | HOME cGMP Manufacturing Protocols and Quality AssuranceIriSys Quality Assurance Unit is responsible for regulatory compliance as directed... Systems. The QA Unit provides final review and approval of the following documents. Protocols Standard Operating Procedures cGMP manufacturing batch records Specifications Final... product release and Certificates of Analysis Stability study testing data Formal reports Company | Preclinical Development | cGMP Manufacturing | Platform Technologies | Regulatory...

Quality Control CONTACT US | EVENTS | HOME cGMP Manufacturing Quality Control UnitIriSys maintains a cGMP compliant Quality Control Laboratory. The Quality Control Unit... testing Company | Preclinical Development | cGMP Manufacturing | Platform Technologies | Regulatory Affairs Blog |Contact Us | Events | Site Map | Copyright | Privacy | Home 8810 Rehco... Road, Suite F, San Diego, CA 92121 Tel (858) 623-1520 Fax (858) 623-1525 IriSys' formulation development scientists and cGMP manufacturing unit optimize the formulation of clinical trial materials. ...