Quality or Regulatory
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Quality or Regulatory Problems ? Let's Talk |
The Problems.......and Their Solutions
We Can Help...You've received an unfavorable regulatory or registration audit...
Company Abstract—Sequitur Associates
We have the experience of running organizations that comply with regulatory and registration requirements while achieving strategic business goals.
We bring over 100 years of management and product experience ranging from:
We specialize in development of management and systems for implementation of ISO and FDA regulations, through assessments of current practice, evaluation and prioritization of issues to root causes, and involvement of employees through implementation of systemic corrective actions by training, hands-on program management, and follow-up to confirm effectiveness.Sequitur also provides services in clinical trials assessment, conduct and design, due diligence activities, product development, regulatory pre-approval audits, start-ups, vendor qualification, etc.
Conveniently located in Morristown, New Jersey, and in San Francisco, California.
Sequitur's Operating Philosophy:
We are very interested in working with you on a confidential basis to resolve your immediate issues. Our ultimate goal is to work with our partners in ways that strengthen their internal understanding of their unique regulatory circumstances.
In this way, our customers develop the ability to deal effectively with quality, regulatory, and clinical issues in ways which assure that the possibility of recurring problems are lessened.
We view these occasions as opportunities to establish long-term working relationships with our new clients.
John Dellinger--President, Sequitur Associates
Ways We Can Help....
- Expertise in sorting out root causes, and developing & implementing corrective action programs that assure your company follows the spirit and letter of appropriate regulations with a minimal downside impact on your business.
- ISO and FDA audits, including assessments of your own and your vendors' product design and process validation processes.
- Assessments of your organization's in-house clinical management activities, and how they translate into preparing your investigators for an FDA Investigator audit.
- Pre-submission assessments of submission documents and substantiation of the device's design, validation, and manufacturing processes. Assesses the capacity of design process to perform good science and document it in a way that will stand close scrutiny at a later date.
- Due-diligence assessments of companies and product lines, providing insight into design substantiation and completeness, management competency, and ability of the manufacturer's process to replicate the design in a regulatory environment.
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Reference Accounts
- UroMed, Inc.
Supra Medical Corporation
Cytyc Corporation
Stryker Biotech Corporation
The Hardardt Group
Creative BioMolecules Corporation
Sullair, Div. Sundstrand Corporation- Cyprus Sierrita
- Hannify & King, PC
- PLC Medical Systems, Inc.
- General Scanning, Inc.
- Enzon, Inc.
- Millenium Medical Supply, Inc.
- Ackrad Laboratories, Inc.
- Medi-Stim AS, Oslo
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Contact Information
We can be reached at the following location. Please e-mail, call, fax, or write with your questions or comments and we will contact you quickly.
- Telephone
- 973-644-9098
- FAX
- 973-292-7594
- Postal address
- 5 Turtle Road, Convent Station, New Jersey 07960
- Electronic mail
- General Information: sequitur@gti.net
Webmaster: sequitur@gti.net
Send mail to sequitur@gti.net with questions or comments about this web site.
Copyright © 1998 Sequitur Associates LLC
Last modified: Aug 30, 1998