1. Your Partner in Delivering Excellence

2. Vision
To be a global leader in contract research industry
by continuous innovation and excellence in quality.

3. Mission
1.To support in discovery and development of new
therapeutics.
2.To ensure compliance with global quality standards.
3.To be a long term trusted partner and collaborate with
pharmaceutical and biotechnology organizations.

4. Outline
Introduction to Sitec Labs Pvt. Ltd.
Company’s History and Executives
Analytical Research Division
Impurity Synthesis & Isolation
BA / BE Division
Regulatory Overview

5. Introduction to Sitec
In
operation
since 2004
More than
350 staff
members
51
Overseas
clients
Office located
in Navi-
Mumbai, India
Total area
75000 Sq/ft

6. Facility Description
Two Facilities
A stand alone 4 storied facility spread
across 75000sq/ft area in Navi - Mumbai.
 1st floor facilitates Analytical Research
department, Impurity Synthesis,
Microbiology, Cafeteria (more than 150
personnel sitting arrangement) and
Accounts department.
 2nd floor having niche Clinical and
Quality Assurance facility.
 Entire 3rd floor dedicated for
Bioanalytical and Quality Assurance.
 4th floor facilitates Analytical Research
division.

7. Facility Description
Sr. No. Name of Instrument Model / Type of instrument Throughput of Instrument / hour
01 Urine Analyzer Siemens Clinitek status / Semiauto 45 Test
02 Clinical chemistry Analyzer Erba Diagnostic EM-360 / Semiauto 360 Test
03 Na/K/Cl Analyzer Medica Easylyte Plus / Semiauto 45 Test
04 Automated Haematology Analyzer Sysmex KX-21 / Semiauto 60 Test
05 Microplate Washer and Reader Bio-Rad 680 / Semiauto
362 Test / 4 Hours.
(HIV / HBsAg / HCV / HAV-Igm)
Screening
NABLAccredited Pathology Laboratory
Volunteer ICF for
participation for
screening
Checking in
OVIS
Volunteer
Registration
BMI ECG Vitals Phlebotomy
Fitness of
Subject for
study
A separate facility for Pathology and Screening, spread across 7500sq/ft area at
Bhandup, Mumbai.

8. Company History
Sitec Labs Pvt. Ltd. was established in Dec
2004 in Mumbai, India.
First regulatory audit in year 2005 (MCC).
First USFDA, WHO and TGA audit in year
2006.
First EMEA audit in year 2007.
Expanded the facility in year 2010 from 30000
sq. ft to 75000 sq. ft. by relocating to Navi-
Mumbai, India.
More then 10 years of successful journey with
approvals from DCGI, USFDA, EMEA,
MHRA, WHO, MCC, GCC, Health-Canada,
MoH of UAE, MoH of Sudan and Danish
authority.

9. Key Personnel
Sr. No Name Education Experience Department
1 Mr. Krishnan Iyer B.Pharm 26 Director
2 Dr Muneesh Garg MD Pharmacology 16
Principal
Investigator
3 Mr. Ratnakar Jadhav M Pharm 11 Clinical
4 Dr. K Raghu Naidu M.Sc., Ph.D. 22 Bioanalytical
5 Mrs. Maraya Campos BSc, PGDAC, PGDIRM 32 Quality Assurance
6 Dr. Zaki Dange M.B.B.S, D.P.B 16 Pathology
7 Mr. Amol Birhade
M.Sc. , Statistics SAS®
certified advanced
programmer
4 Biostatistician
8 Mr. Godwin Koonan BSc, PGDIAC 19 Analytical Research
9 Mr. Jaysingh Singh BSc, PGDTAC 18 Analytical Research
10 Dr. Arvind Sawant M.Sc., Ph.D. 26 Impurity Synthesis
11 Mr. Amol Mohile MBA Operation 15
Project
Management

10. Services Outsourced
Sr. No. Company Name For services
1 Ethiwell Ethics approval
2 Ethos Ethics approval
3 CB Patel Ethics approval
4 Conoisier Ethics approval
5 Parmar Diagnostic X ray facility
6 Rishabh Diagnostic Centre X ray facility
7 Micron Metropolis Healthcare Pvt Ltd Pathology (Additional facility)
8 Suburban Diagnostic Pathology (Additional facility)
9 Sai Snehdeep Hospital Emergency healthcare facility
10 Envio Clean Waste Management
11 Safe House Archival (Additional facility)

11. Services Provided
Analytical Services
Clinical Services
Bioanalytical Services
Analytical Method Development and Validation.
ICH Stability studies
Comparability studies
Forced Degradation studies
Leachable, Extractable studies
Excipient & API analysis
Finished Product analysis
Pilot studies
Pivotal studies
Bioanalytical Method Development and Validation
Bio Sample analysis
Impurities
Synthesis / Isolation studies
Structure Elucidation
Characterization

12. Analytical Research Division
 A fully GLP compliant state-of-the-art facility equipped with sophisticated
analytical instruments. ( Total 60 HPLC’s with 21 CFR compliant software )
 Microbiological testing facility for MLT, BET, PET, Bioassays and Sterility.
 Walk-in Humidity Chambers for stability studies with real time and
accelerated stability evaluation of drug products.
Sr. No. Temperature & Humidity Condition Capacity (Liters)
1 250C & 60% Rh 21000
2 300C & 65% Rh 21000
3 400C & 75% Rh 21000
4 250C & 40% Rh 5000
5 300C & 35% Rh 5000
6 400C & 20% Rh 5000

13. Our Expertise
Development of stability indicating methods.
Method development & validation for particle size,
elemental analysis (ICP-MS & AAS).
Method development for residual solvents.
Performed validation and forced degradation studies
for more than 1050 methods.
Stability studies as per ICH guidelines.
Analysis of food & cosmetics samples.
Tec-Mar studies.
Analysis of elemental impurities and assay using AAS
and ICP-MS instruments.
Polymorphic evaluation using XRD and DSC.
Characterization of molecule using FTIR, XRD, DSC,
CHSN-O and GC-MS.
Analytical Research Division

14. Clinical
 Two independent CPUs of 32 beds capacity
each and one CPU with 18 beds for pilot
studies. Total capacity of CPU is 82 beds.
 Well equipped 2 bedded ICU.
 Pharmacy with walk in humidity chamber.
 Qualified and trained doctors and nurses.
 In-house NABL accredited Pathology
laboratory at Bhandup site, Mumbai.
 More than 11000 volunteers data base
including more than 900 female volunteers.
 Screening facility at Bhandup site, Mumbai.
Image

15. Member of OVIS (Online Volunteers Information System) to avoid
cross participation of volunteers.
Recreation area, Phlebotomy area, Nurses room.
Data management using latest software like SAS-9.4, WinNonlin®
software for pharmacokinetics calculation.
Central monitoring by CCTV of all Clinical Pharmacological Units.
Dedicated sample collection / processing area.
Sample Storage facility comprises up to -86˚C condition Deep
Freezers which are constantly monitored by automated system.
Temperature monitoring of facility performed using wireless data
logging and excursion alarm system.
Clinical

16. Pilot / Pivotal Bioavailability & Bioequivalence studies from 6 to 120 volunteers.
Pharmacokinetics / Pharmacodynamics studies.
Conducting studies on special population. (Post-Menopausal females and Elderly
population)
Fasting, Fed and Steady State studies.
Studies conducted on following type of drug products:
 Solid Oral Formulations – Tablets, Capsules, Sprinkles, Immediate Release,
and Extended Release.
 Oral Dispersible Formulations.
 Inhalers & Nasal Sprays.
 Suspensions & Syrups.
 IVs (Intravenous)
 Dermatological Patches.
 Lozenges, Chewing gums etc.
Our Expertise
Clinical

17. Total 14 LC-MS/MS instruments with latest
model API 6500 providing wide range of
sensitivities.
 Sciex API 6500 (2 systems)
 Sciex API 5500 (3 systems)
 Sciex API 4000 (3 systems)
 Sciex API 3200
 Sciex API 3000 (2 systems)
 Sciex API 2000
 Waters UPLC with QPXE (2 systems)
Image
Image
Bio-analytical

18. Sample Processing Facilities
Robotic Liquid Handling System (EVO 200) from Tecan for high throughput
sample processing.
Ultra sensitive balances.
Cooling centrifuge instruments accommodating sample tubes in different
formats.
Sample concentrators accommodating sample tubes in different formats & 96
well plates.
Dedicated refrigerators and freezers for storage of reference substances and stock
solutions.
Dedicated lab space for execution of very sensitive and light sensitive assays.
Sample Storage Facility
Twelve deep freezers with cooling up to -86°C.
Temperature monitoring performed using wireless data logging and excursion
alarm system.
Bio-analytical

19. Development, validation and execution of very sensitive bioanalytical
methods with LLOQ less than 1 pg/mL.
Developed methods for Fluticasone, Mometasone, Salmeterol,
Salbutamol, Beclomethasone, Budesonide, Ipratropium,
Triamcinolone, Formoterol, Tiotropium, Indaceterol, Glycopyrronium,
Ciclesonide and Azelastine for PK studies of inhalers and nasal sprays.
For Oral contraceptive products like Norethisterone, Levonorgestrel,
Ethinyl Estradiol, Mifepristone, Misoprostol etc.
Methods developed and studies involving over 16 different
antiretroviral.
Our Expertise
Bio-analytical

20. Some of the challenging methods developed and validated:
 Risedronate sodium from “Plasma”
For endogenous compounds like Estradiol and Cortisol.
For compounds usually observed in body fluids from food chain
like Nicotine and Salicylic acid.
For chiral compounds like Bicalutamide (chiral assay).
For light sensitive compounds like Amlodipine, Felodipine,
Nifedipine, Montelukast, Artesunate, etc.
For cholesterol lowering statins like Atorvastatin, Simvastatin,
Rosuvastatin, etc.
Developed and validated more than 200 bio-analytical methods.
Our Expertise
Bio-analytical

21. Our Expertise
Isolation of the impurities on Prep. HPLC.
Identification of unknown impurities formed in stability sample.
Identify the RRT & Mass of these unknown impurities.
Enrichment of these impurities by forced degradation & isolation
of the same.
Identify these impurities as per pharmacopeia or In-house
method of analysis.
Confirm these impurities by spectroscopic analysis.
Provide pharmacopeia/In-house impurities by synthesizing
chemically or by degradation method.
Impurity Synthesis & Isolation

22. Sitec Regulatory Overview
Analytical Research Division
Facility is inspected and approved by
TGA- Australia : April-2006.
FDA- USA : April-2014, May-2011, March-2008 and March-2004.
Danish Authority : July-2014.
Facility registered with Health Canada (Validity till year 2017)
Certified ISO 9001:2008 for Quality Management System.

23. Bioequivalence Division
Facility is inspected and approved by
FDA- USA : Feb-2015, Feb-2014, June-2013, Nov-2011, May-
2010, Sep-2006 and June-2006.
EMEA- European Union : Jan-2011 and Jan-2007.
MHRA- UK : Nov-2013.
MCC- South Africa : Nov-2010 and Jan-2005.
MoH- UAE : April-2007.
WHO : Jan-2014, Feb-2012, Feb-2009, Jan-2008 and Apr-2006.
Authorized centre by DCGI - India, GCC - Saudi Arabia &
MoH- Sudan.
Sitec Regulatory Overview

24. Sitec has conducted more than 950 studies.
Sitec has developed more than 200 bio-analytical methods for bio-
studies.
Level of detection is from µg/ml to fg/ml.
Sitec has good talent pool, infrastructure, all major regulatory
approvals and strong research experience.
Support to client for regulatory query post submission.
Certified ISO 9001:2008 for Quality Management System.
Vast pool of experience in various regulatory requirements and
approvals.
Why Sitec ?

25. Thank You
Address:
Sitec Labs Pvt. Ltd.
Pee-Dee Infotech,
Plot No: Gen-40, TTC, MIDC,
Behind Millenium Business Park,
Near Nelco bus stop,
Mahape,
Navi Mumbai-400710,
India.
Phone No:
Office: +91 22 27786200
Mr. Krishnan – Director : +91 9820549099
Mr. Shailesh – BD: +91 9821118376
Mr. Hermes – BD: +91 7045656923
Email:
support@siteclabs.com