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Akers Kennedy & Associates Inc. is a network of recognized industry leaders dedicated to offering superior technical guidance and assistance with regulatory and validation issues and concerns.
About Us
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AKA has experience and a full understanding of product, process, and manufacturing activities, as well as regulatory trends and issues. We have experience in domestic and international validation, regulatory and quality assurance concerns, and can offer guidance to meet the market needs. Our experience includes pharmaceuticals, bulk chemicals, clinical scale production, biotechnology, aseptic processing and quality assurance.
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Aseptic Processing and
Sterilization |
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Bulk Pharmaceuticals |
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Environmental Control |
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Pharmaceuticals |
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Isolation Technology |
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Solid Dosage Forms |
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Sterilization Technology |
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10 |
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Filling/Labeling/Packaging |
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Biologicals |
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Chemical Product
Manufacturing |
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Biotechnology |
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Quality Assurance/Quality
Control |
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AKA can help you and your company in the following areas by performing or offering assistance in:
GMP Audits
Master Planning
Project Review and Management
Design Review
Validation Issues and Concerns
Quality Assurance/cGMP Compliance
Regulatory Compliance Issues
Protocol Writing
Document Control
Standard Operating Procedure Writing
Preventive Maintenance Programs
Calibration Programs
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