Regulatory Compliance Excellence

 

 

"Remediating Your Consent Decree, Warning Letter, Multi-483s and Quality System Challenges Right First Time and Fast By Spending Less"

 

 

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Client Testimonials

"When Nova wanted to engage a Consulting Firm with extensive experience in both medical device and pharmaceutical manufacturing experience to review some potential process changes in one of our factories, we engaged in a thorough search and chose Pass FDA Inspection Guaranteed (previously known as  TechnoBusiness-Solutions.) Our choice was rather simple; while we found many firms that offered various specialties and a wide-range of consulting experiences, Costas and Barry from Pass FDA Inspection Guaranteed brought nearly 30 yrs of experience each in medical device and pharma R&D and manufacturing process and quality. We outlined our needs upfront, and Costas and Barry fulfilled our needs in just one visit. While our process focus was very specific, they also offered opportunities for improvement in other areas of our business operation that was an added bonus. In short, we found them both very well prepared, extremely knowledgeable and experienced, and also very personable to work with. Their style was open, honest, and targeted on our needs. It was a pleasure working with Barry and Costas!" 

Tom Larkin 

Manufacturing VP, Nova Biomedical, Waltham, MA
Hired Costas and Barry as Pass FDA Inspection Guaranteed consultants in 2009

781-647-3700

Tlarkin@novabio.com


"We placed Costas at one of our large pharmaceutical clients. The team he worked for was extremely pleased with his performance. His work quality was excellent. He completed the projects on time and went above and beyond what they originally brought him in to work on. I would highly recommend hiring him for any contract needs that fit his expertise."  

Top qualities: Great Results, Personable, Expert

Diane Plante
Account Executive, Cost Management Incentives, Inc
Hired Costas as a Business Consultant in 2008

800-509-4248

DPlante@Cost-Management.com


"Costas is a true expert that goes above and beyond to achieve the project objectives for his customers. He immerses himself in the project and has a can do attitude. I am very pleased with what he has helped our company achieve." 

Top qualities: Great Results, Expert, High Integrity

Frank Lesniak
CEO, BPG International

Hired Costas as a Manufacturing Medical Device Consultant

610-565-2661

flesniak@bpginternational.com


"Costas and I worked at Eli Lilly at the same time providing commissioning, qualification, computer systems validation and overall regulatory compliance work for the Parenteral manufacturing facility. Although much of what we did specifically for this client is not to be shared in a public forum, we were involved with periodic reviews that targeted risk-based areas that needed improvements. This was concurrent to some FDA visits, Warning Letters, and 483s. Needless to say, there was a lot of pressure. Costas was a true engineering professional, competent, team-player, gracious, fun-loving, and we developed a very good working relationship. I would not hesitate to work with Costas again; it was an enjoyable and positive experience!"

Mark Westerman, MBA

Validation and Qualification Manager, CREW Co (at Eli Lilly)
Was with another company when working with Costas

317-796-0237

marklwesterman@aol.com


"Costas' knowledge and self-motivation are two of his greatest assets. His experience enables him to put processes and improvements into place very quickly and he has the important, but often overlooked, quality of ethos. People genuinely like working with Costas. His sense of humor and his knowledge-base make Costas a great team leader and an excellent candidate to inform and influence clients."  

John Anderson

Business Development Manager, CH2MHILL
Worked directly with Costas at CH2MHILL

732-560-5700

janderson@ch2m.com


"Costas is very knowledgeable in diverse technologies, regulatory compliance and operational efficiencies. He is detail oriented, efficient and a team player. He always goes the extra mile to make sure the job gets done right and with the least resources. He would be a great asset to any organization." 

John LoPiccolo

Packaging Compliance Project Manager, Schering-Plough
Managed Costas indirectly at Schering-Plough

610-704-9259

jtl62@msn.com

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