Who We Are
ATUSA, L.L.C.: Your Experts in FDA-Regulated Validation Services
ATUSA, L.L.C. is a dynamic team of proficient professionals with over 40 years of combined experience. Specializing in FDA-regulated industries, we offer comprehensive validation services throughout the entire lifecycle of your projects.
With our extensive resources and expertise, we excel at developing complete validation packages for various systems, including process, utility systems, manufacturing, packaging and inspection equipment, laboratory equipment, and computerized systems. Additionally, we cater to all your quality documentation requirements.
At ATUSA, we prioritize collaborative partnerships with our clients to achieve shared business objectives and deliver cost-effective outcomes. Our commitment lies in fostering an atmosphere of equality and fairness when negotiating with customers, suppliers, and partners, always recognizing and respecting our shared interests.
Trust ATUSA, L.L.C. to be your trusted ally in navigating the complex world of FDA regulations and validation services.
Meet our Director of Operations and President: Pedro J. Méndez, Sr.
Mr. Méndez: Expert in Pharmaceutical Industry with 34+ Years of Experience
Mr. Méndez, a highly seasoned professional in the pharmaceutical industry, brings an impressive track record spanning over 34 years. His expertise is diverse, having worked in various capacities in pharmaceutical plants and laboratories. His proficiency lies in validations, product and technology transfers, manufacturing processes, and business management.
Notably, Mr. Méndez has garnered extensive experience leading construction certifications, validations, and quality control projects internationally, including in Brazil, Mexico, and Argentina. With an astute understanding of FDA regulations, he has successfully aided numerous customers in achieving compliance.
Acknowledgment for his remarkable contributions throughout his career comes in the form of prestigious accolades. For instance, Mr. Méndez was honored with the Supplier of the Year Award from Johnson & Johnson, as well as the State Blue Chip Award bestowed by the USA Chamber of Commerce.
The basis of Mr. Mendez’s comprehensive knowledge in the pharmaceutical field is his B.S. in Chemistry from the University of Puerto Rico. This educational background further strengthens his ability to navigate this dynamic industry successfully.
Mr. Méndez also co-wrote the following:
Products in Vials, Ampoules, Syringes and Cartridges. in Practical Aseptic Processing: Fill and Finish ed. Jack Lysfjord (Vol. 1, pp. 275-304). Bethesda, MD: PDA.