'Biosimilars' trends
Domains containing the tag 'Biosimilars'
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- 1finnegan.com
Finnegan | Leading Intellectual Property Law Firm
Full-service IP coverage in all technology and product categories ranging from consumer goods, electronics, medical devices, and manufacturing to ***s and nanotechnology.
Finnegan is a true full-service IP firm handling patent, trademark, copyright, and trade secret law, with experts in every technology.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP is a true full-service IP firm with experts in every area of IP and every technology. A comprehensive approach to clients’ IP needs and Finnegan’s mega-boutique size underpins their year-to-year, decade-to-decade preeminence in IP litigation across all industries and tribunals. From offices in the United States, Asia, and Europe, Finnegan continues to be one of the world’s largest firms focusing on intellectual property, practicing all aspects of patent law, trademark law, copyright law, and trade secret law, representing clients on IP issues relating to U.S. and European patent and trademark law, international trade, portfolio management, the Internet, cybersecurity, e-commerce, government contracts, antitrust and unfair competition.
Finnegan offers full-service IP legal experience and technical expertise in virtually every industry and technology, including biotechnology, ***s, biologics and biosimilars, chemicals, electronic devices and components, computers and software, financial services and business systems, artificial intelligence (AI) and machine learning (ML), digital health, nanotechnology, automotive, a***pace and aviation, industrial manufacturing, consumer products, media, food and beverage, medical devices, clean energy and renewables, robotics, sports and fitness, textiles, and 3D printing.
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- 2gabionline.net
Home - GaBI Online - Generics and Biosimilars Initiative
Generics and Biosimilars Initiative
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- 3creativebiolabs.net
Creative Biolabs, a leading supplier of recombinant antibodies, develops a wide range of antibodies from the***utic antibodies and single domain antibodies to bispecific antibodies and intrabodies.
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- 4pharmamarketnews.com
PharmaMarketNews
Pharma Market News
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- 5centerforbiosimilars.com
Center for Biosimilars®
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- 6amgenbiosimilars.com
Medicine from Biologics Experts | Amgen Biosimilars
With over four decades of experience, Amgen is an end-to-end biologics expert, bringing innovation to the research and development of innovative biologics.
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- 7organonbiosimilars.com
Biosimilar Adoption and Support | Organon Biosimilars
Organon Biosimilars is a focused team at Organon that is here to provide information and resources to help adopt biosimilars and reach biosimilar goals.
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- 8biopharma.com
'BIOPHARMA' Domains and Trademark For Sale
Online reference database and book concerning products and companies. Includes sample monographs. ordering details and contacts for publisher in Rockville, Maryland.
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- 9alora.com
Attention Required! | Cloudflare
abbvie ***s combines advanced science with expertise to make strides in drug and treatment discovery, making a remarkable impact on people's lives
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- 10regulatory.com.ua
Pattern of USA Inc. | 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 *** ingredient
AR – ***sment 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 ***
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 ***ysis
CoFS – Certificate of Free Sale
CP – Centralized procedure (European Union)
CP – Comparability protocol (USA)
CPP – Certificate of *** 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 do***ent/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 adverse event
DDPS – Detailed description of pharmacovigilance system
DMF – Drug master file
DMS – Do***ent management system
DP – Drug product
DS – Drug substance
DSUR – Development safety update report
EA – Environmental ***sment
EC – Ethics committee
eCTD – Electronic common technical do***ent
EDMF – European drug master file
EDT – Electronic data transfer
ENS – Early notification system
EPA – Environmental Protection Agency
EPL – Effective patent life
ePSUR – Electronic periodic safety update report
ERB – Ethical review board
ESPAR – Executive Summary Pharmacovigilance ***sment Report
EUA – Emergency Use Authorization
EWG – Expert Working Group
EWP – Efficacy Working Party
FAR – Final ***sment report
FMEA – Failure mode and effects ***ysis
GCP – Good clinical practice
GDP – Good distribution practice
Generic - Generic drug
GGP – Good guidance practice
GLP – Good laboratory practice
GMP – Good manufacturing practice
GMP – Good management practice
GPP – Good pediatric practice
GPP – Good pharmacoepidemiology practice
GpvP – Good pharmacovigilance practice
GRB – Global Regulatory Board
GRP – Good regulatory practice
GSL – General sales list
GSP – Good statistics practice
GVP – Good pharmacovigilance practice
HCP – Healthcare professional
HEOR – Health economics and outcomes research
HREC – Human Research Ethics Committee
HTA – Health technology ***sment
IB – Investigator’s brochure
IC – Informed consent
ICD – Informed consent do***ent
ICSR – Individual case safety report
IDE – Investigational Device Exemption
IDMP – Identification of medicinal products
IEC – Independent ethics committee
IM – Issue management
IME – Important medical event
IMI – Innovative Medicines Initiative
IMP – Investigational medicinal product
IMPD – Investigational medicinal product dossier
IMRDF – International Medical Device Regulatory Forum
IMS – Information management strategy
INDA – Investigational new drug application (USA)
INDC – Investigational New Drug Committee
IP – Intellectual property
IPO – Intellectual Property Office
IPR – Intellectual property rights
IQM – Integrated quality management
IRB – Institutional review board
IRD – International registration do***ent
IRN – Incident Review Network
IS – Internal standard
ISE – Integrated summary of efficacy
ISRB – Integrated summary of risk benefit
ISS – Integrated summary of safety
KIT – Key intelligence topic
KM – Knowledge management
KOL – Key opinion leader
LCM – Lifecycle management
LLL – Lifelong learning
MA – Marketing authorization
MAA – Marketing authorization application (EU)
MAH – Marketing authorization holder
MAIL – Medicines Act Information Letter (UK)
MAL – Medicines Act Leaflet (UK)
MDCG – Medical Device Coordination Group
MDD – Medical Device Directive
MDEG – Medical Device Expert Group
MDLO – Medical Device Liaison Officer
MDR – Medical device reporting
MERS – Multi-agency electronic regulatory system
MHRA – Medicines and Healthcare products Regulatory Agency (UK)
ML – Manufacturer’s license (UK)
MOU – Memorandum of Understanding
MRA – Mutual recognition agreement
NAP – Nationally authorized product
NBE – New biological entity
NCE – New chemical entity
NCO – Non clinical overview
NCS – Non clinical summary
NDAC – New Drug Advisory Committee (India)
NIMP – Non-investigational medicinal product
NME – New molecular entity
OD – Orphan drug
ODA – Orphan *** Act (USA)
ODD – Orphan drug designation
OIA – Official action indicated
OOS – Out of specification
OTC – Over-the-counter ***
P&R – Pricing and reimbur***t
P – *** only
P to GSL – *** to General Sales List
PA – Product authorization
PAI – Pre-approval inspection
PAR – Preliminary ***sment report
PASS – Post authorization safety study
PAT – Process ***ytical technology
PDE – Personal daily exposure
PER – *** evaluation report
PGD – Patient group direction
PI – Prescribing information
PI – Production information
PIL – Patient information leaflet
PIM – Product information management (EMA)
PIP – Pediatric investigation plan
PMS study – Post-marketing safety study
PMS – Postmarket(ing) surveillance
POM – Prescription-only medicine
POM to P – Prescription-only medicine to ***
PPI – Patient and Public Involvement (UK)
PRSPH – Potential serious risk to public health
PSMF – Pharmacovigilance system master file
PTE – Patent term extension
PUMA – Pediatric-use marketing authorization
PV – Pharmacovigilance
PVAR – Preliminary Variation ***sment Report
QA – Quality assurance
QbD – Quality by design
QC – Quality control
QMS – Quality management system
QOL – Quality of life
QoS – Quality overall summary
QP – Qualified person
QPPV – Qualified person for pharmacovigilance
QRD – Quality review of do***ents [template]
RA – Regulatory affairs
RAPS - Regulatory Affairs Professionals Society
RCFID – Registration Certificate for Import of Drug
RCT – Randomized controlled trial
RDE – Remote data entry
RDS – Repeat dose study
RDT – Rising-dose tolerance
REACH – Registration, evaluation, authorization, restriction of chemicals
RI – Regulatory intelligence
RING – Regulatory Intelligence Network Group
rINN – Recommended international non-proprietary name
RMM – Risk minimization measure
RMP – Reference medicinal product
RMR – Reaction monitoring report
ROI – Return on investment
RoW – Rest of world
RP – Responsible person
RPS – Regulated product submission
Rx – Prescription
S+T – Sampling and testing
SAG – Scientific Advisory Group
SAP – Scientific advice procedure
SAWP – Scientific Advice Working Party
SI – Statutory instrument
SLA – Service level agreement
SME – Significant medical event
SMF – Site master file
SMO – Site management organization
SMQ – Standardized MedDRA query
SOP – standard operating procedure
SPIN – Special interest network
SSC – Scientific Steering Committee
TAG – The***utic Advisory Group
TLV – Threshold limit value
TOC – Table of contents
TOD – Table of decisions
TOPRA – The Organization for Professionals in Regulatory Affairs
TPP – Target product profile
USDA – United States Department of Agriculture
VAI – Voluntary action indicated
WC – Written confirmation
WL – Wholesale dealer’s license
WRAC – Worldwide Regulatory Affairs Committee
WHO - World Health Organization
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- 11interpharm-consultancy.co.uk
Interpharm .... when you want to know about generics...
Interpharm Consutlancy specialist generic advice and market intelligence
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- 12mypfizer.ca
Patient Resource Hub | mypfizer.ca
Please select the medicine that you have been prescribed.
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