Personal Information
Organización/Lugar de trabajo
Chennai India
Ocupación
Product development - Formulation R&D ( $ )
Sector
Medical / Health Care / Pharmaceuticals
Acerca de
Sr.product development scientist s.gurubalaji@gmail.com ; 0091 99 44 33 0834
★ Accomplished scientist in leadership role with 15 +years experience in Product development of Generics ,not limited to i.e. 505 ( j ) ,NDA 505 b (2),ANDS,EU, and for other global markets.
Formulation Development, Technology Transfer
★Project Management,material management,project scope, timeline,budget and risk management.
♦ ♦ Technical Skills:
♦ Granulation, granule coating, encapsulation technology,particle coating
♦ Pan coating – film, enteric coating; pelletization using extruder spheronizer
♦ Formulation development of poorly soluble compounds
♦ Tabletting,capsulation;syrups,suspension;semisolid
Etiquetas
anda
generics
product development
generics#anda#505(j)#product development#infringem
qbd
patents
qbd # anda # pharmaceuticals
cma
cqa`
cpp
manufacturing tablets
nda
rnd
formulation development
research
pharmaceutical
pharmaceutical qbd concepts for drug development
qtpp
ctd
stability studies
emea
drug discovery
stock market
candlesticks
pyrogen
pharmaceutical water
sterile water for injection
water
#antibiotics #disease #generics #medicine #product
#cpp #anda #cma #cpp #cqa #doe #generics #qbd #pro
#drugdevelopment #drugproduct #productdevelopment
#anda #biosimilars #bla #industry #nda #otc #produ
sticking
solidorals
endotoxins
filter validation
bioburden
sterile
injections
technology
formulation
timelines
china
warningletter
dataintegrity
alcoa & alcoa+
qbdpharmaceuticals#processvalidation#validation#pa
qualitypharmaceuticals#processvalidation#validatio
process validation
process
pharmaceuticals#processvalidation#validation#param
litigation
market research reports
sales
europe
efpia
ands
dsc
market analysis
chromatography
growth strategy
excel
good habits
personality development
skills
habit
usability
pastes
ointments
gels
semisolids
syneresis
q3
q2
q1
qtpp#maa#anda#
#cqa#
doe
generic product development with qbd pathway
results
regulatory
compliance
capsules
pills
medicine
healthcare
health
probiotics
nutraceut
dossier
infringement
ip
exclusivity
ipr
gmp
sugar coated tablets
enteric coated tablets
tablets
# validation # process validation #pharmaceutical#
marketing authorisation
regulatory approval
drug development
dosageform design
r&d
drug product
drug substance
dosageform
tablet coating
health canada
clinical
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