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KADVALIDATIONANDCONSULTANTS.COM

KAD

KAD Consultants provides experience and capability in all aspects of validation from facility design through product life cycle validation. Our strengths come from hands on experience, our relationship and access to industry experts to provide you with validation solutions. KAD Consultants provides experience and capability in all aspects of regulatory needs from Pre-Investigational New Drug Application meetings through marketing application approval to post approval lifecycle management.

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KAD Consultants provides experience and capability in all aspects of validation from facility design through product life cycle validation. Our strengths come from hands on experience, our relationship and access to industry experts to provide you with validation solutions. KAD Consultants provides experience and capability in all aspects of regulatory needs from Pre-Investigational New Drug Application meetings through marketing application approval to post approval lifecycle management.
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KAD | kadvalidationandconsultants.com Reviews

https://kadvalidationandconsultants.com

KAD Consultants provides experience and capability in all aspects of validation from facility design through product life cycle validation. Our strengths come from hands on experience, our relationship and access to industry experts to provide you with validation solutions. KAD Consultants provides experience and capability in all aspects of regulatory needs from Pre-Investigational New Drug Application meetings through marketing application approval to post approval lifecycle management.

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Our Team | KAD

http://kadvalidationandconsultants.com/our-team

Ken Domagalski, Managing Partner. Ken has valuable experience in developing a long-range objectives and strategic plan by identifying internal and external strategic issues that could affect growth and profitability. His areas of expertise include Quality, Sterile Manufacturing, Operations, Validations, GMP auditing, warning letter and regulatory strategic consultation, NDA, ANDA and CMC reviews. Ken has led numerous successful FDA, EMEA, MCA and other international cGMP inspection. Ron Stephens brings o...

2

Services | KAD

http://kadvalidationandconsultants.com/services

KAD Consultants provides experience and capability in all aspects of validation from facility design through product life cycle validation. Our strengths come from hands on experience, our relationship and access to industry experts to provide you with validation solutions. This allows KAD Consultants to manage a wide array of projects and assure optimization of all validation activities. Services include review and support of:. New facility design or major modification to existing facility. KAD Consulta...

3

About Us | KAD

http://kadvalidationandconsultants.com/about-us-2

KAD Validation and Consultants, located in Dana Point, California, specializes in evaluation and enhancing validation, regulatory and quality systems. We have the experience, expertise and flexibility to serve as your strategic partner. Our leadership is supported by a team of industry experts to provide Simple Solutions to Validation, Regulatory and Quality System Requirements. Dana Point, CA 92629.

4

Regulatory Services | KAD

http://kadvalidationandconsultants.com/regulatory-services

KAD Consultants provides experience and capability in all aspects of regulatory needs from Pre-Investigational New Drug Application meetings through marketing application approval to post approval lifecycle management. Providing Strategic Regulatory Direction. Serve as FDA U.S. Agent for foreign companies. Provide Regulatory due diligence and application readiness assessment. Preparation and support of ANDA, 505(b)(2), IND and NDA applications in e-CTD format. Dana Point, CA 92629.

5

Quality Services | KAD

http://kadvalidationandconsultants.com/quality-services

KAD Consultants provides experience and capability in all aspects of Quality Systems. We specialize in assessing and enhancing quality assurance and controls from a technical aspect to assure compliance to applicable health authority regulatory requirements. Services Include review and support of:. Organizational Communication Systems to assure Corporate Awareness. Site Quality Risk Management programs. Six System Quality Audits. Internal and External Auditing Program. Dana Point, CA 92629.

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KAD

KAD Consultants provides experience and capability in all aspects of validation from facility design through product life cycle validation. Our strengths come from hands on experience, our relationship and access to industry experts to provide you with validation solutions. KAD Consultants provides experience and capability in all aspects of regulatory needs from Pre-Investigational New Drug Application meetings through marketing application approval to post approval lifecycle management.

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