Bioavailability and Bioequivalence Services

Helping Generics gain first-to-market advantage

Our Bioavailability & Bioequivalence team is experienced in delivering outcomes which are
efficient, timely, high-quality, adhering to regulatory needs in fast track to achieve your first-to-
market strategy.
Our offerings encompass End-to-End Bioavailability & Bioequivalence services which include
study design, conduct, bioanalysis, data standardization and analysis, dossier preparation,
regulatory submissions, and pharmacovigilance.
We can deliver complicated studies with high quality outputs. We have experience in a wide
variety of studies involving multiple doses, different dosage forms, single and double blind,dose
escalation, PK/PD end point studies, Glucose clamp studies, proof of concept and exploratory,
repeat “first in man”, nutritional, special population, drug interaction, injection study, inhalation
study and many more.
All of our infrastructure and systems are setup to guarantee high-quality outputs and compliance
for generics companies. Our state-of-art facilities are approved by DCGI, NPRA Malaysia and self
identified with USFDA. The facilities, systems and processes have been inspected successfully by
the USFDA, WHO, ANSM, AGES, Thai FDA, NPRA & DCGI. Additionally many studies performed
at our facilities are submitted, evaluated and accepted across the globe (eg: Health Canada, EU
member states, Indonesia and Australia).
We are ISO 9001-2015, ISO 27001-2013 certified for Quality Management System and Information
Security Management System. The Clinical laboratories performing pathology testing are
accredited by NABL (National Accreditation Board for Laboratories; ISO15189-2012) and CAP
(College of American Pathologists).

ANSM NPRA ThaiFDA WHO FDA

End to end suite of Bioavailability & Bioequivalence Service Offerings

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
Submission, Data Archival
Independent QA Lab at the fore front of technology
High tech labs supporting Sciex-6500
and XEVO – TQS LC-MS /MS analyses​

State of the art

Pharmacovigilance, bioanalytical lab
Publishing and
BA/BE Studies Submissions
and Data Services

 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

Multiple governance systems

ensure 100% adherence to World-class BE facilities adhering to highest compliance with attention to quality & safety
regulatory guidelines at every stage standards
Independent QA department with
SOPs, training and audits
48-bed CPU in Cancer Bio-analytical testing
P
 re-conduct study approval Hospital of Manipal services
by Manipal Academy of Higher University
Education Ethics Committee –
Manipal GLP 21 CRF Part-11
India’s 1st AAHRPP accredited  tate of the art Bioanalytical
S compliant
EC (Manipal and Mangalore) and Lab Bangalore
similar competent DCGI registered
IECs at Chennai
Mangalore
P
 eriodic certification to ISO 9001,
ISO 27001, ISO 15189, CAP  0-bed facility across
8 Chennai

2 CPUs in Manipal university

S
 elf-identification with USFDA hospital campus

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

20 successful inspections across

5 regulators in the last 10 years

“
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

Bioanalytical Capability: Labs at the forefront of technology

We have state of the art GLP compliant Bioanalytical labs with 21CFR part 11 compliant LC-MS/
MS systems located in Manipal and Bangalore
Bioanalytical Labs are equipped with 12 LC-MS/MS (02 AB Sciex 6500, 04 Waters Xevo TQ-S,
03 Thermo Ultra & 03 Thermo Discovery Max), ICP-MS (Agilent 7700x & 7900 in Class 10000
clean air lab facility) and Roche COBAS-e411
New methods can be developed and validated in 4 weeks

Library of 260+ validated Assays Tailored multi-analyte methods

Expertise in macromolecules
applied across 1000+ studies ready in 4-5 weeks

LCMS/MS for small and
large molecule
ICP-MS for trace elements
Precision levels of up to
0.4 pg/mL
08 different matrices
including bone and skin
Multiple approaches with
different instrument platform
Highly sensitive method
for Mometasone (1 pg/
mL), Fluticasone (1 pg/mL),
Formoterol (0.4 pg/mL) &
Tiotropium (0.5 pg/mL)
E.g., Insulin, Glargine and
its metabolites, Octreotide,
Teriparatide, Liraglutide,
C-peptide etc.,
Expanding our expertise in
mAbs

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

About Navitas Life Sciences

Navitas Life Sciences delivers platform-driven full-service Clinical, Regulatory and Safety solutions and
services. As the dedicated life sciences brand of TAKE Solutions, Navitas Life Sciences operates across
North America, Europe, Asia pacific and Latin America. Navitas Life Sciences combines the knowledge
and experience of three legacy brands - Ecron Acunova, Navitas, DataCeutics, KAI Research and Intelent.
Thus, Navitas brings together the capabilities of a full-service CRO, a technology-led life sciences services
provider, and expertise in analytics and data sciences to address critical challenges and drive outcomes
for life sciences. Navitas Life Sciences has over 30 years of rich experience across 400+ phase I-IV clinical
trials, 20+ therapeutic areas, and 40+ successful GCP/non-GCP audits. Our trial expertise is augmented by
OneClinical, a platform that delivers trial oversight, analytics, and insights to drive successful study outcomes.

For more information

Americas +1 609 720 1002 Europe +49 69 668 0300 APAC +91 44 4590 9000
contact@navitaslifesciences.com www.navitaslifesciences.com /company/navitas-life-sciences

© Navitas Life Sciences