Panexcell Clinical Lab Pvt Ltd

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Clinical Lab Private Limited R 374, TTC MIDC, Rabale Navi Mumbai - 400 701 Maharashtra Bio Availability & Bio Equivalence Studies

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MISSIONTo 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. VISIONTo become a world class CRO ensuring conformance to the highest ethical and quality standards.Constantly endeavoring for growth and consolidation of clinical services.

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Core values at PanexcellQuality 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.

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OverviewEstablished 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 Overview @ Panexcell

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OverviewExperience: 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

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

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Capabilities/Expertise@PanexcellPK / 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)

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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

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Standalone services at PanexcellStand Alone Services Regulatory Services Bio Analytical Services Bio-statistical & Medical Writing Quality Assurance Medical writing Project Management

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Clinical Unit at PanexcellIndia 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 900 + female volunteers and 14,000+ male volunteers Separate pharmacy with controlled access World-class infrastructure to support clinical activities Capacity to handle approx. 2000 Volunteers /Year (7500 dosing)

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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 ArchivesClinical Unit: Phlebotomy

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Clinical Equipments in CPUECG 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

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Bio-analytical LabSpread 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

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Bioanalytical facilitiesLC-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)

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

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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

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Biostatistics 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 Pharmacokinetics / Biostatistics / CDM

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Feasibility AssessmentStudy ConfirmationAgreement with ClientProtocol PreparationProtocol Approval by clientIEC submission & ApprovalRegulatory ApprovalScreeningClinical Phase (housing, dosing, sampling, discharge, ambulatory sample)Method Development Method ValidationClinical Data CompilationStats report + Analytical report + Clinical reportSample AnalysisStatistical AnalysisPK AnalysisQC & QA CheckDraft report to clientFinal Report Dispatch to ClientArchival Project Flow

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OrganogramManaging DirectorQuality AssuranceHead OperationsDirector (Technical)DocumentationBioanalytical QAClinical QAClinicalClinical InvestigatorBusiness DevelopmentMaintenanceITPKBSPhysicianMedical Writing Project ManagementChief Scientific OfficerAdminBioanalytical

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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) Key Personnel

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Panexcell Clinical Labs Pvt. Ltd.Contact us: Panexcell Clinical Lab Private Limited R-374, TTC MIDC, Rabale, Navi Mumbai – 400701, India Tel: +91 22 3969 7979 Fax: +91 22 3969 7999 E-mail: info@panexcell.com www.panexcell.com Thank You

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Last Updated: 8th March 2018

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