1. Bio Availability & Bio Equivalence Studies
Clinical Lab Private Limited
R 374, TTC MIDC, Rabale Navi Mumbai Maharashtra
Bio Availability & Bio Equivalence Studies

2. MISSION
To be one of the most trusted partners of our clients through compliance to all regulatory standards in the development of drugs to improve the quality of human life.
To build long-lasting relationships with our clients by providing quality data in a timely and cost-effective manner through our team of experienced and dedicated professionals.
VISION
To become a world class CRO ensuring conformance to the highest ethical and quality standards.
Constantly endeavoring for growth and consolidation of clinical services.

3. Core values at Panexcell
Quality Quality is our primary value. We ensure quality in our compliance in processes, credibility of data and excellence of deliverables.
Customer Focus Our management, processes and people are aligned towards satisfying the needs of our customers. We are dedicated to service excellence that gains us customer continuity.
Knowledge We acquire knowledge in order to lead in our field. We share our knowledge with our people and our customers.
Commitment We are committed to our mission and to our stakeholders. Our commitment is a promise that we will always perform to the highest of their expectations.
Trust We deliver what we promise with honesty and integrity, thus earning the trust that fosters long term relationships.

4. Overview Overview @ Panexcell Established in Sept. 1998
Central Headquarters at Mumbai, India
New facility became operational : 2007
New Management : Mr. Umesh Mishra – since 2011
Total area of 20,000+ sq. feet distributed across 3 floors, 175+ professionals operating in various divisions
Fully Compliant with ICH GCP, ICMR, DCGI, USFDA, UKMHRA, MOH Malaysia and Schedule – Y Guidelines
Supported by 10 high end LC-MS/MS machines, with more than 250+ validated analytical methods for high throughput
More than 15,000 active study participants in database

5. Overview Experience: Consistency: Global Footprints :
18+ years of pharmaceutical experience for National & Global clients
50+ Pharma and Biotech Sponsors all over the globe
1000+ successful clinical studies
Consistency:
Less than 10% attrition YOY
More than 80% Repeat Business
Global Footprints :
Operations : India
Business Offices in India, USA, China and Australia

6. Regulatory Inspections & Study Approvals
HPRA, Ireland
2017
DCGI (2017)
(Drug Controller General, India)
MHRA, UK
2016
US-FDA (2015)
US-FDA (2014)
HSA, Singapore 2015
MoH Kazakhstan
(2012)
TGA, Australia
2014
MoH Turkey (2012)
MoH Turkey (2008)
MCC, South Africa (2008)
MoH, Malaysia (2012)

7. Capabilities/Expertise@Panexcell
PK / PD studies
Bioequivalence / Bioavailability studies
Pharmacokinetic / Pharmacodynamic studies in Healthy subjects
Special / Patient Population studies
Food effect / Drug – Drug Interaction studies.
Proof of Concept studies
End-to End Service
Protocol to Report
Project Management
Final submission Report (e CTD / ICH E3)

8. Clinical Capabilities @ Panexcell
Biostatistics & Medical Writing
Sample Size and Power Calculation
Medical writing and literature search
Providing Statistical Inputs during Protocol Designing
Randomization
Statistical Analysis Plan (SAP)
SAS Programming and Validation
Interim Analysis
Statistical Report

9. Standalone services at Panexcell
Regulatory Services
Bio Analytical Services
Bio-statistical & Medical Writing
Quality Assurance
Medical writing
Project Management

10. Clinical Unit at Panexcell
India
60 Beds arranged in 2 study areas spread over 8,000 sq.ft. at central office
2 Intensive Care beds with cardiac monitoring
Access controlled wards
Data base of 15,000+ healthy volunteers including female volunteers and 14,000+ male volunteers
Separate pharmacy with controlled access
World-class infrastructure to support clinical activities
Capacity to handle approx Volunteers /Year (7500 dosing)

11. Clinical Unit: Phlebotomy
Phlebotomy area with separate matrix processing room
Separate dining area with in-house kitchen
Screening room
Counseling room with audio-video recording facility
Ambulatory room
Examination and monitoring rooms
Recreation hall
Archives

12. Clinical Equipments in CPU
ECG machine
Pulse Oxy meter
Defibrillator
Suction machine
Ambu bag and oxygen cylinder
Digital synchronized clocks
Pharmacy chambers
Cold centrifuge
Deep freezer
Glucometer
Biometric system
Alcohol breath analyzer

13. Bio-analytical Lab Spread over 4,000 sq. ft. space
Wet lab with multiple processing counters
Dark room for light-sensitive molecules
10 LC-MS/MS machines ( API 3000, 3200,4000, 5500 and Thermo Discovery.)
Equipment and software compliant to 21 CFR part 11
Micro-balance room
Chemical storage room
Central monitoring with CCTV
Solid Phase Extraction systems.
Nitrogen evaporators
Capability to analyse 10,000 > samples/month

14. Bioanalytical facilities
LC-MS/MS:
API 5500 (3)
API 4000 (2)
API 3200 (2)
API 3000 (2)
Discovery (Thermo Finnigan)
UV Spectro/Micro-plate reader
Fume hoods
Automated sample evaporators
Balance: Analytical and micro balance
Cold centrifuge
Deep freezers (-200C & -700C)

15. Expertise (Formulations & Therapeutic Areas)
Antibiotic/ Antimicrobial
Antidepressant
Antiepileptic
Antiretroviral
Hormone
Hypoglycemic agents
Lipid lowering agents
Muscle relaxants
NSAIDs
Psychotropic agents
Formulations
Oral Solids – Capsules, Tablets, Softgels, Granules, ODT, ODP, Modified Release
Liquid Orals
Parenterals
Transdermal patches
Topical Gel
Cream
Inhalers
Nasal Sprays

16. Quality Assurance
Quality Assurance at Panexcell is an independent function reporting to CSO and ensures ethical conduct of clinical studies as per GCP, GLP & other applicable regulatory requirement
Quality Control (QC) Procedures in place apart from Quality Assurance (QA) Procedures
All activities are subjected to rigorous review for Quality Assurance including
Clinical (over 50 SOP’s), Bio-analytical, PK / Stats / Reporting
Internal Audits by QA team for Area Specific SOP compliance
In-house capabilities to perform Site Audits, Systems / Process Audit, Vendor Audit
All QA systems are compliant with all applicable local & international regulations
Quality Assurance
Monitoring Visit and Audits
Inspection of Documents
Site Qualification
Inspection Readiness
Development & Maintenance of SOP
CAPA
Training to Staff
Review of Project Plans

17. Pharmacokinetics / Biostatistics / CDM
Panexcell has an experienced and dedicated team of SAS programmers & Biostatistician Personnel.
Services offered:
Statistical Analysis Plan
Sample Size Calculation
Randomization
Efficacy and safety assessment
Statistical Data Analysis
Statistical Inference

18. Project Flow Feasibility Assessment Study Confirmation
Agreement with Client
Protocol Preparation
Protocol Approval by client
IEC submission & Approval
Method Development
Method Validation
Regulatory Approval
Screening
Clinical Phase
(housing, dosing, sampling, discharge, ambulatory sample)
Clinical Data Compilation
Sample Analysis
QC & QA Check
PK Analysis
Statistical Analysis
Stats report + Analytical report + Clinical report
Draft report to client
Final Report Dispatch to Client
Archival

19. Organogram Managing Director Director (Technical)
Chief Scientific Officer
Head Operations
Business Development
Quality Assurance IT
Maintenance
Admin
Bioanalytical
Project Management
Clinical
PKBS
Medical Writing
Clinical Investigator
Physician
Clinical QA
Bioanalytical QA
Documentation

20. Key Personnel Mr. Umesh Mishra (Managing Director)
Mr. Manojit Pathak (Director - Technical)
Dr. Yati Chugh (Chief Scientific Officer)
Mr. Manoj Shukla (Head - Operations)
Dr. Nitin Kulkarni (Head - Clinical & Principal Investigator)
Mr. Pankaj Kasar (Head - Bioanalytical)
Mr. Sriram Eswaran (Head - Quality Assurance)
Dr. Mamata Jadhav (Project Management )
Dr. Yogesh Barde (Manager - Business Development)

21. Panexcell Clinical Labs Pvt. Ltd.
Contact us:
Panexcell Clinical Lab Private Limited
R-374, TTC MIDC, Rabale, Navi Mumbai – , India
Tel: Fax:
Thank You