What We Do
We offer solutions to leading firms who need support and flexibility in responding to current and future challenges in the following areas:
- Business Strategy and Expansion
- Business Transformation
- Capital Project Development and Management
- Employee Training and Development
- Facility Engineering and Maintenance
- Leadership / Management Coaching
- Lean Six Sigma Training and Deployment
- Organizational Design
- Product Serialization and ePedigree Process Implementation
- Project Management
- Quality Control and Quality Assurance—Investigation Processes,
Batch Review & Release, Shop Floor Coaching - Regulatory Affairs – Compilation, Authoring, Publishing, Submission (paper & eCTD of ANDA, BLA, DMF, IND, NDA, etc.) and Agency Interface Services
- Regulatory Compliance—Mock Audits, Inspection Preparation,
Audit Response, & Remediation - Technical Transfer, New Product Development & Launch Optimization
- Staff Augmentation and Support
- Supply Chain Management—Sales & Operations Planning,
Inventory Management & Optimization