LATINO AMERICA CONSULTORES COMPANY PROFILE. Update Version , June

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1 LATINO AMERICA CONSULTORES COMPANY PROFILE 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_Cmpany Prfile_2014_5 0_eng Pagina 2 di 18

3 Cntents 1. Latin America Cnsultres Overview Cmpany Operatin Additinal Services and Methdlgy Address 6 2. Latin America Cnsultres Main References Suth America References Cperatin in Eurpean Prject Middle East Nrd Africa Events, Technical Seminars & Public Cnferences 9 3. Prcess & Quality Services Regulatry Affairs Quality Assurance Prcess Qualificatin & GxP Supprt Business Develpment Supprt & Internatinal Regulatry Supprt Engineering & Validatin Engineering - Oral Slid Dsage Frms Cmpliance IT (& Autmatin) 17

4 1. Latin America Cnsultres Overview Latin America Cnsultres since its fundatin, had wrked in cperatin with Internatinal Partners, t be able t integrate the lcal cmpetences with the nce f the Internatinal Partners, t supply the mst adequate supprt t all the Custmer lcated in Center and Suth America. The Cperatin with Internatinal partners, allws Latin America Cnsultres t prvide an Internatinal State f the ART supprt, sharing with these partners the mst recent Apprach, Methdlgy and Technlgies. Funded in 2008, t supprt Custmer s Prject in Bth, lcal (ANMAT) and cgmp/eu-gmp Regulated Envirnment, in nly 6 years f cntinuus activity has becme ne f the Reginal Leading GMP Cnsultancy Cmpany. Fllwing the market requirements evlutin, fr bth GMP Regulatry and GMP Prductin Cmpliance, LAC culd prvide custmer supprt cvering the fllwing areas: R&D Research & Develpment Cnsultancy fr Business Prcess Re-Engineering Cnsulting fr cmpany (and crprate) rganizatin, supprt Prcess change and Structure changes Technlgy Transfer Engineering (Design & Refurbishing) Regulatry Cmpliance Supprt Industrial Prcess Qualificatin Supply Chain Optimisatin Quality assurance & Quality Cntrl Infrmatin Technlgy System Integratin, Infrastructure Management & Optimisatin, IT Cmpliance Our experts team, incrprates a wide range f skills, prviding cverage t manage all stages f prduct life cycle in cmpliance, fr Prductin, Quality Prcess and Business Develpment.

5 1.1. Cmpany Operatin LAC - Latin America Cnsultres cunt n Team f cnsultant, using a standard methdlgy, including Prcess Mapping Tls, Risk Analysis Tls, reprting tls. The LAC Staff is rganised as a Grup f Prject Manager, wh can individually cntrl the external cntractr team r the Custmer s Team/Resurces. The main expertise is fcused n the fllwing services areas: Prcess & Quality Scale Up & Technlgy Transfer Supprt Strategic Business Supprt (Prductin Strategy, Prduct Prtfli Management) Quality Assurance & GMP Prcess Supprt Auditing Regulatry (Natinal & Internatinal) Prcess Qualificatin Engineering & Validatin Feasibility & Cnceptual Design & Engineering Supprt Revamping Third party Design Qualificatin Qualificatin supprt fr Utilities & Plant, Supprt fr Prcess Autmatin) IT t Cmpliance (IT & Cmpliance Cnsultancy, System Integratin, Cmputer System Validatin and GMP Cmpliance Infrastructure Management) Thrugh its wn expertise LAC is able t supprt all needs f custmers in terms f prduct life cycle steps, frm frmulatin t finished prducts release, in cmpliance with internatinal requirements. Quality by Design & Risk Management are the bases f ur internal methdlgy and prject management behaviur. LAC perates supprting Multinatinal Pharmaceutical Organisatin, Natinal & Lcal Pharmaceutical Cmpany, API Prducer and Cntract Manufacturers. LAC Latin America Cnsultres, has its wn ffice in Buens Aires, and Uruguay, cvering frm here, and in cperatin with partners, all the Latin American Cuntries; LAC can Operate in all Sur America, supprted by lcal partner in Mexic and Brazil.

6 1.2. Additinal Services and Methdlgy LAC wrks with CTP since its/his beginnings in 2008, CTP can prvide a netwrk f partners in Eurpe supprting peratins, regulatry fr Licensing and Strategic Cnsulting. Actually CTP is invlved in Internatinal prjects cncerning: Internal Business Prcess Re-engineering (Strategic, Operatin, Prcess Optimisatin, QA/Quality Management System, GMP Review, LEAN, SWAT) Technlgy Transfer Supprt (Internal frm R&D t Prductin &/r between different sites) Regulatry Supprt (Strategic fr Prduct & Standard fr Dssier Registratin & Variatins) The internal CTP Methdlgy is inspired and aligned t the last requirements and Guide Line, using a Quality by Design (QbD) and Risk Based Apprach frm Design t Qualificatin (ICH-Q8, ICH Q9 ICH-Q10, GAMP 5) CTP is an active member f many Pharmaceutical Assciatin, such as AFI, PDA, ISPE, PLG) Address Latin America Cnsultres Carls Villate 1661 Oficinas 3 y 4 - (1636) Olivs - Buens Aires - Argentina Tel/Fax / Web

7 2. Latin America Cnsultres Main References 2.1. 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

8 2.2. 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 2.3. Middle East Nrd Africa Medis(Tunisia) Remede Pharma (Algeria)

9 2.4. 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;

10 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

11 3. 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 3.1. 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.

12 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

13 3.3. 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

14 4. 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

15 4.1. 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

16 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

17 5. Cmpliance IT (& Autmatin) Intrductin This expertise may supprt IT Prject in Regulated Envirnment as Pharmaceutical, fr bth, Cmpliance/Validatin Issues and Infrmatin Technlgy. As a brief verview, the main services supplied by IT t Cmpliance Area are: Feasibility Studies URS defintin Supplier Qualificatin & Supprt fr Sftware Selectin GMP & System Risk Assessment Prject Management Cmputer System Validatin 21 CFR Part11 Cmpliance Remediatin Prgram Supprt Prviding GMP Cmpliant Slutin Trainings Supprt fr IT Infrastructure Management (ref.: ISO 20000, ITIL, BSI-7799) IT Netwrks Qualificatin Abbtt Feasibility study BPCS versin validatin GMP Training CSV Training 21CFR11 Training Sessin 21 CFR Part 11 DCS Assessment and Remediatin Plan Definitin GMP Assessment fr the shp flr cntrl system Autmatic Machines Validatin BPCS Upgrade Validatin (2004) (2007) Ttalchrme Validatin (upgrade ) GMP Site Risk & Prcess Analysis SCADA Validatin (2007) AMEGA Bitech GEMA Bitech Plant GXP Assessment fr Cmputerised System Validatin Master Plan fr Cmputer System Validatin Executin f Cmputer System Validatin and 21 CFR Cmpliance Prject

18 Antibitics LIMS validatin (2003/2004) QC Remediatin (2007) Empwer Validatin (2007) Antibitics (Len) Prcess Autmatin Assessment Risk & GAP Analysis Remediatin Plan DCS Validatin (2003/2004) Labratri Hidalg OCASA Rvafarm 21 CFR Part 11, GAMP 5 and Cmputerised System validatin Training Prject Assessment Supprting System s implementatin Cmpliance Activities Cmputerised System Validatin Supprt Training Prcess Assessment SAP System Functinal Assessment SAP Validatin Training Prject Assessment Sftware Validatin Temmler Wireless Warehuse System Validatin (2004) Dispensing System Update Validatin Supprt 21CFR Part 11 Internatinal Assessment Prgram Supprt SAP vers. 6.0 Prting Validatin Empwer Validatin

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