Welcome
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.
Area of Expertise
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.
Services List
| 1. Aseptic Processing and Sterilization | 7. Bulk Pharmaceuticals |
| 2. Environmental Control | 8. Pharmaceuticals |
| 3. Isolation Technology | 9. Solid Dosage Forms |
| 4. Sterilization Technology | 10. Filling/Labeling/Packaging |
| 5. Biologicals | 11. Chemical Product Manufacturing |
| 6. Biotechnology | 12. Quality Assurance/Quality Control |
Services
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