 |
|
 |
|
| Strategic Compliance International, Inc. |
|
Strategic Compliance International, Inc (SCI) specializes in helping companies build and maintain effective worldwide regulatory
compliance. Our team of international experts offers cost-effective solutions for a wide range of regulatory compliance and quality
assurance challenges for biologics, medical devices and drug companies. |
|
| Areas of focus: |
|
|
|
|
|
|
- Qualification and Audit of Contract Laboratories
& Manufacturing Facilities
- Quality Systems-cGMP Assessment and Audits
- Development of Quality Systems Manuals
- Supplier/Customer Audits and Supplier Management
- Pre-Approval Inspection Preparation
|
|
|
- Microbiological Assessment of Manufacturing Processes
- Method and Laboratory Equipment Validation
- Documentation Development and Management
- Laboratory Quality Systems
|
|
|
|
- Planning and Development of Technology Transfer
Strategies
- Master Plan Development
- Development of Documentation Systems & Regulatory
Submissions
- Strategies for Process and Method Transfers
|
|
|
|
- Planning and Development of Training Programs
and Curricula
- Development of Lesson Plans
- Regulatory Compliance - cGMP
- Hot Topics Workshops Series and other customized,
in-house training
|
|
|
|
- Regulatory Compliance Review
- Regulatory Affairs Submissions
- Documentation Development and Review
|
|
|
|
|
|
|
|
 |
Strategic Compliance International, Inc., 2500 Regency Parkway, Cary, 27511
Phone: (919) 460-3900  Fax:
(919) 460-4689
carmen@sci-nc.com www.sci-nc.com
|
|
|
|
|
|
|
|
