Validation and Technical Validation and Technical ServicesServicesUrb. Mónaco 2, 2 España Street, Manatí, Puerto Rico 00674

P.O. Box 852, Manatí, Puerto Rico 00674-0852Tel. 787-884-4206 / Fax 787-854-6554

www.alphatechinc.comPedro J. Méndez, President, Cel. 787-549-9797

Email: mendezpj@alphatechinc.com

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IntroductionIntroduction

• Alpha Tech, Inc. offers a full range of validation and engineering services, from training to the validation of an entire facility. We perform product and technology transfer, GMP audits, New Drug Applications / Supplemental New Drug Applications evaluation, and equipment troubleshooting and maintenance.

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IntroductionIntroduction

• Our company has the resources and the experience to deliver complete validation packages for process, utility systems, manufacturing, packaging, and inspection equipment, laboratory equipment, and computerized systems. We also provide services for your quality documentation needs.

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IntroductionIntroduction

• We work side by side with our customers to reach common business goals and to produce economical results. We are committed to conduct business and to negotiate with our customers, suppliers, and partners in an equal and fair fashion recognizing our mutual interests.

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Company HistoryCompany History• Fourteen years serving the

pharmaceutical, biotechnology and medical devices industries

• President: Pedro J. Méndez• Main Office: Manatí, Puerto Rico• Branch Offices:

– Allendale, New Jersey– Metepec, México– Sao Paulo , Brazil– Buenos Aires Argentina– Dallas, Texas

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ServicesServices• Validation Services

– Equipment and process validations– Validation Master Plans, Design

Qualification, Factory Acceptance Tests, Site Acceptance Tests; Installation, Operation, Computer, and Performance Qualifications

– Cleaning validation– Computer Systems validations– 21 CFR Part 11 assessment– Filter certifications– Facilities design and qualification consulting

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ServicesServices

• Quality Systems– Good Manufacturing Practices (GMP)

audits– Pre-Approval audits– Specifications– Standard Operating Procedures

(English/Spanish)– Product and Technology transfers– GMP Facilities Certification

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The Company has a line of very satisfied customers which includes the following (list not all-inclusive):

• Aventis• Abbott Chemicals• Abbott Pharmaceuticals• Allergan Medical Optics• American Home Products• Amgen Manufacturing• Bristol Myers Squibb• Bristol Myers (former

Dupont)• Biovail Laboratories• Cardinal Health• Eisai U.S.A., Inc.• Genentech, Inc.• IPR Pharmaceuticals, Inc.

• Medimmune (Maryland)• Merck Sharp & Dohme• Johnson & Johnson• Laboratorios Teuto

Brasileiro • MOVA Pharmaceuticals • Novex Pharma (Canada)• Paco Puerto Rico Inc.• Pfizer (including former

Pharmacia and Warner Lambert)

• Wyeth• Ivax Pharmaceuticals

CustomersCustomers

List not all-inclusive

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U.S. and International U.S. and International Locations ServicedLocations Serviced• California• Chicago• Indiana • Louisiana• Massachusetts• Minnesota• New Jersey • New York• North Carolina• Pennsylvania• Texas

• Argentina• Brazil• Canada• Denmark• Germany• Ireland• Italy• Japan• Mexico• Netherlands• Switzerland• Uruguay