Related by context. Frequent words. (Click for all words.) 63 Manufacturing Practice GMP 63 Manufacturing Practices GMP 59 SFDA approval 58 GMP compliant 57 CE Marking 55 ISO Certification 54 Marketing Authorization 53 ISO #:# Certification [002] 53 cGMP 53 Manufacturing Practices 52 SFDA 52 ISO #:# certification [001] 52 Orphan Drug designation 51 GRAS status 51 ISO #:# certification [002] 50 GMPs 50 ISO certification 50 ISO TS # 50 Abstral 49 ISO #:# Quality 49 Orphan Drug status 49 GMP certified 48 USFDA 48 Biologics License Application 47 ingredient API 47 Aseptic 47 orphan designation 47 ISO #:# [002] 47 Swissmedic 47 OHSAS # 47 Drug Administration USFDA 47 Type Approval 46 certification 46 regulatory approval 46 Helsinn 45 Loramyc ® 45 Certification 45 Point HACCP 45 excipient 45 lyophilization 45 Renhuang 45 Hovione 45 ingredients APIs 45 Marketing Authorization Application MAA 45 excipients 45 Orphan Drug Designation 45 OFIRMEV 45 Sancuso 45 taliglucerase alfa 44 Microbix 44 Hylenex 44 lyophilized 44 Skouries 44 TPIAO 44 Active Pharmaceutical Ingredients 44 pediatric exclusivity 44 accreditation 43 BLA submission 43 ONSOLIS 43 Marketing Authorization Application 43 BENLYSTA 43 Regulatory Approval 43 ISO #:# [003] 43 ISO certified 43 conformity assessment 43 Accreditation 43 HACCP 43 cGMP manufacturing 43 CHMP opinion 43 life'sDHA TM 43 DSM Biologics 43 Mutual Recognition 43 Microbiological 43 Eden Biodesign 43 accreditations 43 Biologics License Application BLA 43 requisite regulatory approvals 43 approval 43 Approvable Letter 43 Priority Review 42 UKAS 42 Onsolis 42 ISO # 42 vitro diagnostic IVD 42 IND enabling 42 approvals 42 Bioxel 42 orphan medicinal product 42 PLIVA dd 42 Fast Track designation 42 Omnitrope 42 FDA Clearance 42 aseptic 42 IMVAMUNE R 41 Scientific Advice 41 Relistor 41 Icatibant 41 Drug Application 41 BioDelivery Sciences 41 CCHIT Certified ® 41 ANDA