ATC Corporation of Indianapolis
When Direction Matters
Our Background
ATC Corporation of Indianapolis is women owned and operated and was established in 1993 as a regulatory support and technical training organization. ATC provides services to the pharmaceutical, biotechnological, medical device, OTC and specialty chemical industries. Today, our operations have expanded to provide Regulatory Compliance Support Solutions to address all aspects of validation and compliance.


Our Team
People make all the difference and, in the fast paced world of manufacturing and validation, proficient and capable personnel are essential. ATC provides its clients with highly qualified regulatory consultants. Our personnel meet a rigorous set of requirements, which includes a minimum of a four-year degree in their field of instruction and annual attendance at continuing education courses supporting their field of specialization.  Each member of the ATC team is able to communicate important compliance issues and negotiate cooperative resolutions that are appropriate for each of our clients.


Our Expertise
ATC Corporation of Indianapolis specializes in assisting organizations to identify and quantify risks, and implement policies and programs to manage the validation of regulated computer systems, quality systems, internal auditing, regulatory compliance and enforcement, and the full range of GMP, GLP, GCP and QSR requirements. Our expertise has assisted clients worldwide for projects of all sizes.


Our Style
ATC Corporation of Indianapolis partners with your organization to provide expert consultants and engineers with knowledge and experience in government and industry regulations. We tailor our services to your organizations' specific needs and apply proven methodologies and tool sets to accomplish objectives.
 
Whether you need the support of one service, or choose to leverage our fully integrated services,  ATC Corporation of Indianapolis understands and meets the deadlines which are critical elements to your business success. Through innovation and seamless execution, our commitment to client satisfaction delivers measurable results, providing your organization with the cutting edge on compliance issues.
 

Our Guarantee
ATC Corporation of Indianapolis stands behind its personnel and the programs offered in this guide. ATC will attend and explain any documentation, personnel assignments and backgrounds, experimental plans or executed programs performed by ATC or its agents during any audits conducted by Occupational Safety and Health Administration [OSHA], the Food and Drug Administration [FDA] or any other regulatory agency.   This guarantee is unique in the consulting industry.

Our Products
ATC offers a wide range of services to assist the pharmaceutical, biotechnological, medical device, OTC and specialty chemical industries in bringing new products to market.  We assist throughout the entire product life cycle with a special emphasis in meeting client objectives in a timely, cost effective manner.  The ATC delivery model is flexible and client-focused, enabling our teams to rapidly respond to changing client needs and market conditions.


  • Compliance Auditing
    • Simulated Pre-approval Inspections
    • Vendor Audits
    • Due Diligence Audits
    • Software Quality Assurance Audits
  • Strategic Compliance Consulting
    • Strategies for Interfacing with Regulatory Authorities
    • Compliance Abatement
  • Quality Systems Consulting
    • Quality System Design and Introduction
    • Quality System Gap Assessments
    • CAPA Program Design and Implementation
  • Information Technology Consulting
    • Information Technology Assessment
    • Information Technology Validation
    • Electronic Records and Electronic Signatures
  • Validation Planning
    • Equipment Qualification
    • Utility Qualification
    • Process Validation
    • Cleaning Validation
    • Computer Validation
    • Methods Validation
  • Training and Technology Consulting
    • In-House Training Assessments
    • Training Program Design and Implementation
  • Project Management Consulting
    • Project Planning from Start to Finish
    • Easy-to-use, Secure, Web-based Solution
    • One Integrated Solution to Manage People, Process, Time & Costs
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