Auditing • Consulting • Pre-Approval Inspection Preparation and Support in Document and Personnel Management During Inspections • Quality and Regulatory Services
Don
Hill & Associates will perform independent audits of the following:
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Client facilities, and documentation for compliance with cGMP regulations and guidance;
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Third-party audits of contract manufacturers and contract laboratories;
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Audits of fill/finish facilities and operations (drugs and biologics);
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Audits of Quality Systems
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Assessment of isolators for in-process/filling operations
We
conduct mock pre-approval inspection audits and assist clients to identify
gaps, and to develop and implement action plans to address the gaps. Our
services provide for systems-based inspections to assess Quality, facilities
and equipment, materials, product, packaging and labeling, and laboratory
control.
We provide comprehensive assistance to ensure clients understand current regulatory agency interpretation and application of regulations. We work with our clients to develop systems and procedures to implement and ensure ongoing compliance. This can include:
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Technical/regulatory assessment of product development and manufacturing of monoclonal antibodies, vaccines, chemical synthesis and polymer like products;
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Assessment of Quality Systems;
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Development of Corrective and Preventive Action (CAPA) programs, deviation and investigation reports, EM procedures, facilities / process validation, analytical laboratory compliance, tracking and trending of system performance;
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Assistance in design of new and renovated manufacturing facilities;
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Due diligence to support mergers, venture capital investments and acquisitions;
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Development and implementation of effective regulatory strategies with focus on INDs and NDAs / BLAs, Master Files and EU dossiers;
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Prepare, edit or review of CMC submissions to regulatory agencies including INDs/CTAs, BLAs, NDAs ,and marketing applications in Common Technical Document format, Master Files, and meetings with regulators;
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Prepare or review the responses to review letters or questions from FDA or other regulatory agencies;
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Expertise in complying with regulator expectations regarding gene and cellular therapy products with experience in both the regulatory and cGMP compliance aspects of these products;
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Assistance in preparing responses to form FDA 483 observations and / or warning letters;
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Provide in-house training programs on cGMPs and other specialized Quality or Regulatory topics
We
assist manufacturers to prepare for global regulatory agency inspections
and support the logistics of the inspection, such as management of documents
and staff during the inspection. Specific activities include:
- Perform
risk assessment and gap analysis;
- Develop
and implement action plans;
- Conduct
mock pre-approval inspections;
- Train
/ coach company personnel who will interact with regulatory agency
inspectors and;
- On-site
implementation of a proven program to support staff and document management
during inspections.
QUALITY
AND REGULATORY SERVICES
High
quality, easy to read documents are essential to obtaining rapid, product
review by a regulatory agency. We will complement and assist your staff
in developing, writing or reviewing documentation. Our staff can assist in
the preparation
of CMC sections of the following:
IND
/ CTA, and BLA, NDA, EU dossier using the ICH Common Technical Document
format. Additionally, we can write or review Master Files, validation
documents, procedures, batch records and other controlled documents required
by you or your contract manufacturer.
Don Hill & Associates, Inc
Main Office (301) 260-2200 Fax (301) 260-2020
eMail: dhai@msn.com
