Bioavailability and Bioequivalence Services: Helping Generics Gain First-To-Market Advantage
Bioavailability and Bioequivalence Services: Helping Generics Gain First-To-Market Advantage
Bioavailability and Bioequivalence Services: Helping Generics Gain First-To-Market Advantage
M
ethod Development, Validation and
End to end Services and Solutions for study sample analysis
Generics Companies D
ossier preparation D
ynamically updating method library
to address industry requirement
R
egulatory Submission
C
hallenging methods
S
tudy Design, Study Conduct, R
edacted reports for
Subject recruitment and regulatory inspections A
vailability of different LC-MS/MS
Project Management platforms
P
harmacovigilance activities
B
ioanalysis, PK and Statistics E
lemental analysis and LBA capability
R
egulatory Compliance –
D
ata Standardization in CDISC- SOPs built upon regulatory S
cientifically designed and compliant
complaint format guidelines systems and processes
M
edical Writing, eCTD Independent QA Lab at the fore front of technology
Submission, Data Archival
High tech labs supporting Sciex-6500
and XEVO – TQS LC-MS /MS analyses
mart administrative approach and adherence to the timelines are critical for the filing and in turn ROI
S
linical facilities at multiple locations (a logistical advantage) capable of accommodating studies with
C
bigger sample sizes
igh-end instrumentation capacity to absorb the bolus load with shorter TAT
H
Clinical Capability: Database of 20K+ registered volunteers and ready access to diverse populations
M
ost recent inspection (May 2019) 8
0-bed facility across
and the past inspections from 2 CPUs
USFDA have been tremendously
successful with zero observations
2
Diverse populations to meet your study needs
“
Inhalation
studies Very impressive
clinical set-up systems and
23 k 700 processes, could see
Males
post the consistency in
”
menopausal study conduct
1k females
Females – FDA inspector
Patients
208 Oncology,
CPU Beds Hypertensive,
with ICU Diabetic and
Renal
Euglycemic
clamp bed
facility for
insulin studies
LCMS/MS for small and Multiple approaches with E.g., Insulin, Glargine and
large molecule different instrument platform its metabolites, Octreotide,
Teriparatide, Liraglutide,
ICP-MS for trace elements Highly sensitive method
C-peptide etc.,
for Mometasone (1 pg/
Precision levels of up to
mL), Fluticasone (1 pg/mL), Expanding our expertise in
0.4 pg/mL
Formoterol (0.4 pg/mL) & mAbs
08 different matrices Tiotropium (0.5 pg/mL)
including bone and skin
3
Our Experience and Key Differentiators
Top 10
Indian and
top 30
global pharma
companies
1000+
Bioequivalence
studies for 100+
submissions in marketing
6 continents authorization
approvals
Key
Differentiators 260+
50+ validated
satisfied customers bioanalytical
(Generic & Innovator methods
Pharma companies)
Highly skilled
team of
50 specialists
led by 8 qualified
medical
practitioners and
3 PhDs
O
ur practice of delivering high quality and Delivering Priority Submissions for
compliant studies in a cost effective manner and Clients (Examples):
within timelines, have earned us long standing client
educed “Protocol to CDISC Submission”
R
loyalty
Cycle Time by 50% for a NCE-1 Submission
W
e help bring your products to market faster to USFDA
Bioanalytical methods can be developed in 4 weeks
educed “Protocol to CDISC Submission”
R
O
ur PK domain expertise is often sought by Cycle Time by 69% for a First to File (FTF)
formulators to make improvements submission to USFDA