Consulting Services
The success of BenAstrum Life Sciences Institute’s Consulting branch can be attributed to the elite network of experts, a perfect blend of former FDA personnel and senior professionals highly regarded in the life sciences industry.
Let us assist you achieve your objectives in the following areas:
- ANDA/NDA/DMF Submissions
- Analytical Research & Development
- Aseptic Processing
- Analytical Chemistry
- Clinical Trial Management
- Computers & Automated Control Systems
- Documentation Control
- Facility Design, Validation & Operation
- FDA Quality Systems Strategy
- GMP Documentation
- GCP & GMP Compliancy
- IT/MIS
- Instrumentation
- Investigations
- Lab Design
- Lab Organization
- Microbiology
- Pre-Audit Preparations for Regulatory Bodies, FDA, MHRA, EMEA, Health
- Quality Management Systems
- Quality Control
- Quality Systems Implementation
- Project Management
- Regulatory Affairs
- Risk Analysis
- Responding to Regulatory Inspection Reports, Warning Letters, etc
- Standard Operating Procedures
- Stability Testing and Expiration Dating
- Technical Agreements
- Validation Support (Development, Planning & Equipment)
- Validations
