 |
 |
| Chrai Associates, advisors to the Pharmaceutical, Device and Biotechnology Industries, provide result oriented consulting based upon expertise that reflects practical experience using real life examples and case histories: |
 |
|
| Regulatory & Compliance Services |
| |
|
 |
Compliance & QMS |
| |
Audits
- GMP / PAI / Mock
- Plant Approval
- Avoidance & Management
- Form 483 Observations
- Warning Letters
- Consent Decree
Development of Quality Management System
- Document Management and Controls
- Management of Investigations
- Deviations / OOS / CAPA
- Change Control System
|
|
|
|
Regulatory Affairs |
| |
Preparation of Regulatory Documents
- NDA, 510 (k), BLA, ANDA, SNDA, IND, DMF, International Dossier
Pre Approval Inspection
Mock Audits
FDA Relationship Management
Foreign Agent
Annual Product Reviews |
|
|
| ENGINEERING SERVICES |
| |
|
|
Validation & System Qualifications |
| |
Procedures and Protocols
Validation Master Plan
Computer Systems Validation
Equipment Design and Qualification
System Design and Qualifications
HVAC & Water System Qualifications
Validation Change Control Program
GMP Facilities Designing
Risk Management Analysis
Development of Quality Management System |
|
|
| Regulatory & Compliance Services |
| |
|
|
Product Development |
| |
Process Development and Optimization
- Parenteral Products
- Aseptic Processed
- Terminally Sterilized
- Liposomal & Suspensions
- Powders for Reconstitution
- Aqueous & Non Aqueous
- Small & Large Molecules
- Drug Delivery Systems
- Controlled and Modified
- Liposomes
- Aerosols – MDI & DPI
- Transdermals
- Semisolids
- Creams & Lotions
- Ointments & Paste
- Gels & Suppositories
- Solid Dosage Forms
|
|
|
|
Process Development |
| |
Technology Transfer
Package Development & Validation
Process Development & Validation |
|
|
|
Development and Validation of Technologies |
| |
Aseptic Processing Techniques
Sterilization Technologies
Barrier Technology Techniques
Filtration Technology
Containment of Potent Drugs
Lyophilization Technology
Liposome Technology
Electrostatic Deposition Technology
Cold Chain Distribution System |
|
|
|
Analytical Method Development and
Validation |
| |
Aseptic Processing Techniques
Release & Stability Indicating Methods
Cleaning Method Development and Validation
Container Closure Integrity
Laboratory Systems and Specifications
Stability Testing & Expiration Dating |
|
|
|
Manufacturing Operations |
| |
Manufacturing – API & Finished Product
Aseptic Processing Manufacturing
- Contamination Controls
- Media Fills
- Sterilization and Sanitization
Terminally Sterilized Products Manufacturing
Non-Sterile Products Manufacturing
Maintaining GMP Manufacturing Operations
Outsourcing Assessment & Management
Trouble Shooting – API & Finished Product
SUPAC Requirements & PAT Initiatives |
|
|
|
Outsourcing Programs |
| |
Selection of CMO & CRO
Due Diligence and Audits
RFP & Proposal Evaluation
Technology Transfer Procedures
Quality & Supply Agreement
Program Implementation & Monitoring
Risk Management |
|
|
| TRAINING SERVICES |
| |
|
|
Customer Tailored On-site Courses and Training Programs in the area of: |
| |
GMP and Compliance
Regulatory and Inspections
Leadership and Management
Technical and Manufacturing |
|
