LATINO AMERICA CONSULTORES REFERENCE LIST. Update Version , June

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1 LATINO AMERICA CONSULTORES REFERENCE LIST Update Versin , June Latin America Cnsultres Carls Villate 1661 Oficinas 3 y 4 - Olivs - CP 1636 Teléfn: /

2 Dcument Cntrl Versin Cntrl Versin Data Authr Issue s Reasns 1.0 (2013) 2.0 (2013) 1.0 (2014) 2.0 (2014) 3.0 (2014) 4.0 (2014) 5.0 (2014) January, 2013 G. Rssi First review 2013 August, 2013 G. Rssi Secnd Review 2013 January, 2014 G. Rssi First review 2014 February, 2014 G. Rssi Secnd Review 2014 March, 2014 G. Rssi Third Review 2014 April, 2014 G. Rssi Furth Review 2014 June, 2014 G. Rssi Fifth Review 2014 LAC_Refecrence List_2014_5 0_eng Pagina 2 di 13

3 Cntents 1. Latin America Cnsultres Main References Suth America References Cperatin in Eurpean Prject Middle East Nrd Africa Events, Technical Seminars & Public Cnferences 6 2. Prcess & Quality Services Regulatry Affairs Quality Assurance Prcess Qualificatin & GxP Supprt Business Develpment Supprt & Internatinal Regulatry Supprt Engineering & Validatin Engineering - Oral Slid Dsage Frms 12

4 1. Latin America Cnsultres Main References 1.1. Suth America References Bag BMS ELEA Finadiet Gema Bitech Hlliday Sctt Inghenia Kilab Labratri Aristn Labratri Casara Labratri Casasc Labratri Drreg Labratri Hidalg Labratri Kemex Labratri Omega Labratri Rayms Labratris Dispert SA LABYES LKM Mead Jhnsn Mega Pharma Micrsules Mntpellier OCASA Pierre Fabre Rvafarm Syntex

5 1.2. Cperatin in Eurpean Prject Hungary Human Biplazma KFT Richter Geden (Geden Richter) Teva Italy Abbtt Antibitics Astellas Aventis Kedrin Janssen-Cilag Nvartis Pathen Recrdati Temmler Yamanuchi Wyeth Zambn Prtugal Lusmedicamenta (ex. Janssen-Cilag) Spain Antibitics Len Merck Sharp & Dhme 1.3. Middle East Nrd Africa Medis(Tunisia) Remede Pharma (Algeria)

6 1.4. Events, Technical Seminars & Public Cnferences Fr mre infrmatin, please visit Latin America Cnsultres Web-site: ETIF Cnferences: Pharmaceutical Utilities GAMP 5 Overview Risk Based EBRS Implementatin using GAMP 5 Cntaminatin cntrl accrding t Annex I 2009 Pharmaceutical Technlgy - Technical Publicatin: Exprting in Eurpe Annex I EU-GMP CILFA Cnference: Eurpean Market Sindusfarma: Cmputer System Validatin & GAMP 5 Universidad de Belgran Cnference: Cmputer System Validatin Gbiern de la Ciudad de Bs. As.: Cnference Cycle related t: Internatinal Pharmaceutical Exprtatin Rules fr Pharmaceutical Prduct Eurpean Registratin Gbiern de la Ciudad de BsAs: Supprting launch f Freign Trade Database; 2010 Universidad de Belgran Cnference Prduct Traceability Overview f Internatinal On-Ging Regulatin & Prject Sindusfarma Cnference: Prduct Traceability Overview f Internatinal On-Ging Regulatin & Prject (Cntrl de Autenticidad y Trazabilidad de Medicaments) ETIF 2010: Participatin t the 1st Rnda de Negci Cnference: CTD and Reginal Variatins f CTD Cnference: MENA and (Caspian región r east Eurpe) pharmaceutical markets and regulatins Cnference: Internatinal and ANVISA tracealibility requirements, en el marc del Cngres ETIF 2010 Pharmaceutical Technlgy Magazine - Technical Publicatin: Trazabilidad de Medicaments;

7 2011 ExpFybi 2011: Cnference: Trazabilidad de ls Prducts Farmacéutics Cnference: Available Technlgies Participatin t Rnda de Negci ExpFybi 2011 Sindusfarma 2 nd Wrkshp Cnference: Prduct Traceability Overview f Internatinal On-Ging Regulatin & Prject 2011 Updates Gbiern de la Ciudad de Bs. As. Cnferencias: Aspects Regulatris Internacinales Seminari sbre Requisits para la Exprtación EMEA/FDA 2012 ETIF 2012: Cnference: Cnferencia Validación de SAP: Su impact en el Desarrll del Negci Participatin t Rnda de Negcis ETIF 2012

8 2. Prcess & Quality Services Intrductin This expertise may supprt implementatin, review f Quality related issues, and related Quality System Prject fr daily activities, including Regulatry Services. As a brief verview, the main QA and GMP Prcess services supplied are: Auditing Regulatry Affair GMP and GLP Supprt & GMP Review Prcess & Impact Assessment Supprt fr Technlgy Transfer Managing, Reviewing and Submit Regulatry Dcuments (CTD, ectd, APR, QPR, EBR) Supprt fr Quality Management System Implementatin & Review Supprt fr Authrities Inspectin Supplier & Raw material Qualificatin In Huse Training Public Training 2.1. Regulatry Affairs Bag Internatinal Regulatry Affairs and GMP Trends training. Bristl Myers Squibb Training Regulatry Affairs Supprt Labratris BAGO Training LABORATORIO CASASCO Internatinal Regulatry Affairs training.

9 LABORATORIO CASARA Internatinal Regulatry Affairs and GMP Trends training. MEAD JOHNSON (BMS Buens Registratin f a new labratry in Argentina and transference f BMS prducts t Mead Jhnsn. Labratris MONTPELLIER Internatinal Regulatry Affairs and GMP Trends training Quality Assurance Prcess Qualificatin & GxP Supprt ELEA Risk Assessment Labratri Drreg (Mntevide) Assessment Supprting Quality Management System Review and New Quality Management System Implementatin Labratri Omega Internatinal GMP Audits and Cnsultancy. Eurpean GMP Cnsultancy fr veterinary fd prducts Pierre Fabre Prcess Validatin Quimica Mntpellier Training Syntex Training Supprting Business Develpment

10 2.3. Business Develpment Supprt & Internatinal Regulatry Supprt Finadiet Training Business Develpment Activities Internatinal Regulatry Affairs Hlliday Sctt Extended GMP Cnsulting Activities Business Develpment Supprt Kilab Business Develpment Activities Partner Identificatin Alliance Management LKM Business Develpment Activities Internatinal Regulatry Affairs Mead Jhnsn Business Develpment Activities Partner Identificatin Alliance Management Micrsules Business Develpment Activities Internatinal Regulatry Affairs

11 3. Engineering & Validatin Intrductin This Expertise may supprt Design, Prject Management, Cnstructin, Cmmissining, Qualificatin, Revamping & Maintenance engineering activities related t Plant and Equipment. As a brief verview, the main tpics cvered are: ENGINEERING Basic & Cnceptual Design Value Engineering Prject Management Start-up & Cmmissining QUALIFICATION&VALIDATION Impact Assessment Validatin Master Plan Design Qualificatin Installatin Qualificatin, Operatinal Qualificatin, Perfrmances Qualificatin GAP Analysis Remediatin Prgram Supprt Calibratin & Maintenance Warehuse Envirnmental Mnitring Supply Chain Cntrl Implementatin

12 3.1. Engineering - Oral Slid Dsage Frms Kilab Supprting Cnceptual Analysis fr new Plant Prject LABYES Engineering & GMP Supprt Validatin Master Plan Preparatin Cnceptual & Feasibility Design Labratri Aristn Engineering & GMP Supprt GMP Plant Assessment Supprting Equipment and System Validatin Supprting Plant Engineering and refurbishing Activity Supprt Varius Plant Refurbishing Plans Labratri Dispert (Uruguay) Engineering & GMP Supprt Prduct Strategic Analysis Cnceptual & Feasibility Study Labratri Omega Engineering, Qualificatin & GMP Supprt GMP Assessment GMP Review Value Engineering Qualificatin & Validatin Labratri Kemex Equipment Validatin

13 Labratri Rayms Engineering, Qualificatin & GMP Supprt Sftware validatin Purified Water System Validatin Regulatry Affair Supprt Cleaning Validatin Supprt Mead Jhnsn Engineering, Qualificatin & GMP Supprt Cnceptual design Advanced Basic Design Prcurement Mega Pharma (Uruguay) Quality Management System Sftware Validatin Design Qualificatin Supprt fr the New Plant Mead Jhnsn New QC Facilities Cnceptual Design Cst evaluatin GMP review URS definitin Suppliers evaluatin and crdinatin Prject Management Cmmissining Qualificatin & Validatin

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