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tlidevelopment.com - Ressources et information concernant tlidevelopment Resources and Information.

tlidevelopment.com réunit des informations et annonces. Nous espérons que vous y trouverez les informations que vous recherchez !

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auditing.com

auditing.com auditing.com           
Auditing - The Auditing Group and Validations.com GMP - GLP - GCP Part 11 Audits
Auditing, GMP, Audits, Audit and GMP Auditing Part 11 and Part 820 Auditing and Training services for the Pharmaceutical, Biotechnolgy, Medical Device, Food and Cosmetic Regulated Industry by Industry Professionals. FDA.COM is the next step for professionals seeking compliance information through discussion groups and on-line information sharing. Directed by John Cuspilich, Director Regulatory Affairs and Michael Van Horn, Director Sales and Marketing, companies can get noticed by over 100,000 visitors monthly. GXP Academy is the world's leader in GMP Training and GMP Management Auditing services. GMP Publications is the world's leader in GMP Mini-Regulation Handbooks serving the regulatory community in search of 21 Code of Federal Regulations. Serving the Global Community by assisting global harmonization, and through the International Conference of Harmonization



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nhlbismartt.org

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nhlbismartt.org - Ce site web est à vendre ! - Ressources et information concernant nhlbismartt Resources and Information.
Ce site web est à vendre ! nhlbismartt.org réunit des informations et annonces. Nous espérons que vous y trouverez les informations que vous recherchez !



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regulatory.com.ua

regulatory.com.ua regulatory.com.ua           
Patern Ltd. | Regulatory Affairs Outsourcing ft Pattern of USA Inc. Homepage, FAQ
510(k) – Premarket Notification for Medical Device aka PMN
AADA – Abbreviated antibiotic drug application
ACTD – ASEAN common technical dossier
ADR – Adverse drug reaction
AE – Adverse event
AIM – Active ingredient manufacturer
AIMD – Active implantable medical device
ANDA – Abbreviated new drug application
API – Active pharmaceutical ingredient
AR – Assessment Report (European Union)
ASMF – Active Substance Master File
ATMPs – Advanced therapy medicinal products
BA – Bioavailability
BAP – Biotechnology Action Program
BIND – Biological investigational new drug
BLA - Biologic License Application
BWP – Biotech Working Party (EMA)
C&P – Chemistry and Pharmacy
CA – Competent authority
CANDA – Computer assisted new drug application
CAP – Centrally authorized product
CAPA – Corrective action and preventive action
CAPLA – Computer Assisted Product License Application
CCDS – Company core data sheet
CD – Controlled drug
CDSCO – Central Drug Standard Organization (India)
cGLP – Current good laboratory practice
cGMP – Current good manufacturing practice
Cl – Total body clearance
CLO – Clinical overview
CLS – Clinical summary
CMC – Chemistry – manufacturing – controls
CMP – Certificate of Medicinal Product
COA – Certificate of analysis
CoFS – Certificate of Free Sale
CP – Centralized procedure (European Union)
CP – Comparability protocol (USA)
CPP – Certificate of pharmaceutical product
CQA – Clinical quality assurance
CR – Controlled release
CRO – Clinical Research Organization
CSI – Core safety information
CSP – Core safety profile
CSR – Clinical study report (European Union)
CT – Clinical trial
CTA – Clinical trial application
CTA – Clinical trial authorization
CTD – Clinical Trials Directive
CTD – Common technical document/dossier
CTMS – Clinical trial management system
CTS – Common technical specification
CVM – Center for Veterinary Medicine (US)
DACS – Detailed and critical summary
DAE – Discontinuation due to an a


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regulatoryone.com

regulatoryone.com regulatoryone.com           
Regulatory One
Regulatory One is THE ONE PLACE , worth visiting, to know about Drug Regulatory Affairs, lucid presentation of information related to Drug Regulatory Affairs. Interview Q and A, links to websites of regulatory agencies, updated news and guidelines are also provided.


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rpd-ch.com

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Rapid Pharma Development Outsourcing-Management of your Pharma Development Proje
Since 2007 Rapid Pharma Development provides Development Services for Pharmaceutical Projects. With our long and broad experience in the drug industry, we advance your project into the clinic and further to market authorization.



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auditoneglobal.com

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IMP Dossier
IMP Dossier


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GMP API audits | GxP 3rd-party audits for medicinal products | blue
blue inspection body is Europe's leading provider of accredited GMP audits of API, excipient and finished dose manufacturers of medicinal products



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Biopharma Excellence - Biotech is Our Business
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GMP Expertise for Your Safety: up-to-date, practice-oriented and inspection-proven. Regulations | Recommendations | Templates ... Always stay up to...


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globalsubmit.com

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GlobalSubmit eCTD Submissions Software | Certara
Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences i


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