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- Validation, Compliance, and Regulatory Consulting Services
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- Home
- Service Areas
- Careers
- Contact Us
- Keiper & Associates, Inc. was formed in 2000 as a professional
consortium positioned to provide technical consulting services to the
pharmaceutical, biotech, and medical device Industries.
- We assist our clients by navigating the maze of regulatory requirements,
performing regulatory baseline assessments, and charting practical
experience based compliance strategies that are proven to exceed
regulatory expectations.
- As a true consortium, KAI has the strength and flexibility necessary to
form industry alliances with specialists- allowing us to draw from a
vast pool of retired FDA
professionals, industry experts, and junior professionals. This
diverse set of skills and broad knowledge base allows us to better meet
your compliance, validation, and regulatory requirements.
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- Home
- About Us
- Careers
- Contact Us
- We provide a full range of consulting services to the pharmaceutical,
biotech, and medical device industries. We are focused on exceeding the
regulatory requirements for compliance with U.S., European, and Canadian
agencies and organizations.
- Validation Services (Computer Systems, Lab Systems, Manufacturing
Systems)
- Validation Strategy Development
and Master Planning
- Part 11 Compliance
- Protocol Development, Execution, Review, and Summary Reports (IQ, OQ, and PQ)
- Third Party Review & Project Management
- Validation Remediation/Special
Projects, including interim control solutions
- Validation Baseline Assessments and GAP Analysis
- Compliance Services
- cGMP, GCP, GLP Strategy Development
- Mock FDA QSR/cGMP, GCP, and GLP Inspections
- PAI and Readiness Inspections
- Due Diligence Auditing
- Third Party, Supplier, and QSR Vendor Audits
- Regulatory Services
- Correspondence, 483 ,and Warning Letter Responses
- Consent Decree Compliance and Strategies
- Application assistance
- Data Integrity Assurance
- Corrective Action Plan Guidance
- Learn More...
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- Home
- About us
- Service Areas
- Contact Us
- We are continuously seeking highly motivated, industry professionals,
technical experts, and former FDA officials to join our consortium.
- We welcome you to submit your resume by e-mail to resumes@keiperassoc.com
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- Home
- About us
- Service Areas
- Careers
- Corporate Office
- 34377 Branch View Lane, Suite 100
- Dagsboro, DE 19939
- 302.547.1095 (p)
- 302.541.5572 (f)
- Info@keiperassoc.com
- We are proud to be a members
- Delaware BioScience Association
- New Castle County Chamber of Commerce
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- We are proud of our success in the pharmaceutical, biotech, and medical
device industry. We have partnered with some of the best in the
industry; here are some of our success stories from this year. To learn
more about us and our services please contact us.
- Successfully performed GLP audit
of a contract laboratory on behalf of a pharmaceutical company
involved in the development of innovative compounds for unmet medical
needs.
- Audit highlights consisted of :evaluating resource qualifications,
training, recordkeeping, procedures, validation status (instruments,
computer systems), validation methodology, quality program/methodology,
reagents and solution handling/storage/documentation, master schedule,
study plans/protocol, protocol deviation process, data management (e-record practices included)
- In partnership with a leading regulatory consulting company conducted
baseline assessment of quality systems of an FDA enjoined client and its
subsidiaries.
- This assessment included the following areas: laboratories (R/D and
QC), validation status of global computer systems (LIMS, ERP,
TrackWise, BlueMountain, Web-based Safety Database, Web-based Clinical
Trials Database), status of computer controlled/integrated lab
equipment , status of computer controlled/integrated process equipment,
status of computer controlled/integrated critical utilities, SDLC
methodology, CSV methodology, supporting procedures, and change control
management.
- Provided guidance and regulatory (483 responses) strategy to a
Pharmacovigilance solution provider for clinical trial safety and post
marketing surveillance. Responses
successfully accepted by FDA.
- In partnership with a leading regulatory consulting company provided
consent decree remediation strategies and management of protocol and
work plan activities.
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