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Products and Services for Regulatory Publishing Activities - 515 Consulting Group515 Consulting Group | Electronic Regulatory Submission Solutions

e-Regulatory and e-submission publishing and solutions

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guerraconsultinggroup.com
FDA Regulatory Compliance - Mentoring, Coaching, Consulting and Training
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510k.org
510k, FDA 510(k), UL, CCC Mark, CE Mark, CE Marking - Wellkang® LLC - world leading regulatory consultancy
Wellkang LLC - world leading regulatory consultancy in FDA 510(k), UL, CCC Mark, CE Mark, CE Marking.

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winthroppublishing.org
Winthrop Publishing Company Canada
Winthrop Publishing Company Canada. Publishing books, Artist Portfolio CDs, and Websites. Want to make your ideas available to the world? Try WPC, a Maritime publishing company

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lonestarpharmtox.com
Welcome!
LoneStar PharmTox LLC is an experienced pharmadevelopment and toxicology consulting company with the additional formulation, manufacturing, packaging and regulatory affairs necessary to assist in reducing development cycle time and to bring innovative, safe and sustaining products to market,toxicology consultant, tox consultant, nanotechnology,safety

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weballey.net
WEBalley - web publishing made easy
Excellent html tutorials and web design guides. Free web templates to help beginners writing their first basic homepage. Tips on how to use graphics on your website. Tutorials to teach you everyting you need to know to create and publish your first website. Online home page wizard, online search engine submission, web design resources directory.

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fdacg.com
FDA Compliance Consultants | FDA Consultant | FDA Consulting Services | FDA 483
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horn-pharma.de
Horn Pharmaceutical Consulting - ASMF, Active Substance Master File, US-DMF, Drug Master File, Certificate of suitability, CEP, CTA ,Clinical Trial Application, IND, Investigational New Drug Application, CTD, Common Technical Document, European MAA, Marketing Authorization Application, NDA, New Drug Application / BLA, Biologic License Application, SPCs, Summary of Product Characteristics, clinical or nonclinical study protocols and reports, clinical or nonclinical summaries and overviews, qualit
HORN Pharmaceutical Consulting provides regulatory and business advice to companies from the pharmaceutical, biotechnology and medical device industries.

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aquamarinegroup.com
Welcome to The AquaMarine Group, Inc.
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fda-registration.com
FDA Registration & US Agent Service for non-US manufacturers of pharmaceutical and medical devices, foods and food products offered by Wellkang® LLC - FDAagent.us - FDA-Registration.com
FDA Registration & US Agent Service: FDA U.S. Agent services for non-US manufacturers of pharmaceutical and medical devices, foods and food products offered by Wellkang® LLC - FDAagent.us - FDA-Registration.com

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Validation Plus, Inc.
Validaton Services, Validation Engineering, Good Tissue Practice, 21 CFR Part 11 solution provider

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515-consulting.com
Products and Services for Regulatory Publishing Activities - 515 Consulting Group
e-Regulatory and e-submission publishing and solutions

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Viglya: promoting science, honoring life - promoting science, honoring life
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Accurate FDA Consultants - Worldwide FDA Experts for Medical Device, IVD, Pharmaceutical Industries
Worldwide FDA Experts for Medical Device, IVD…

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otherppl.com
otherppl podcast
Otherppl with Brad Listi is a weekly literary podcast featuring in-depth interviews with today's leading authors. Launched in 2011. New episodes every Wednesday.

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European Life Science regulatory affairs and quality compliance - Med-Di-Dia
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newfoundjournal.org
Newfound | An Inquiry of Place
Newfound is a nonprofit publisher based in Austin, Texas. Our work explores how place shapes identity, imagination, and understanding. The journal is published tri-annually and features fiction, poetry, nonfiction, visual arts, reviews, and more. We also publish poetry chapbooks through our annual Gloria E. Anzaldúa Poetry Prize.

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Life Sciences Perspectives -
Life Sciences Perspectives -

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ectdoffice.com

eCTD Office - eCTD (NeeS / VNeeS) Publishing Software Solution

Mono eCTD Office is a suite of integrated NeeS / eCTD software products for the validation, creation, viewing, manipulation and archiving of NeeS / eCTD submissions of regulatory documentation by pharmaceutical companies to the regulatory authorities.

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unsolicitedpress.com
Unsolicited Press
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dynateklabs.com
Dynatek Labs - Dynatek Labs
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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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Projector — Create to captivate
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anthiazammit.com
Anthia Zammit Legal
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brandinst.com
BRAND INSTITUTE IS THE TOP BRANDING AGENCY FOR PHARMACEUTICAL BRANDING
Brand Institute performs pharmaceutical branding, biotechnology, and consumer branding, naming, and brand name development services for the pharmaceutical, biotechnology, health care, and consumer industries.

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