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Helping Clients Help Themselves
Chrai Associates advisors are industry recognized subject matter experts (SMEs) in their field and provide result oriented global consulting based upon expertise that reflects practical experience using real life examples and case histories. |
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| REGULATORY & COMPLIANCE SERVICES |
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Compliance & QMS |
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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
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Regulatory Affairs |
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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 |
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| ENGINEERING SERVICES |
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Validation & System Qualifications |
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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 |
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| TECHNICAL SERVICES |
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Product Development |
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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
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Process Development |
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Technology Transfer
Package Development & Validation
Process Development & Validation |
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Development and Validation of Technologies |
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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 |
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Analytical Method Development and
Validation |
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Aseptic Processing Techniques
Release & Stability Indicating Methods
Cleaning Method Development and Validation
Container Closure Integrity
Laboratory Systems and Specifications
Stability Testing & Expiration Dating |
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Manufacturing Operations |
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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 |
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Outsourcing Programs |
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Selection of CMO & CRO
Due Diligence and Audits
RFP & Proposal Evaluation
Technology Transfer Procedures
Quality & Supply Agreement
Program Implementation & Monitoring
Risk Management |
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| TRAINING SERVICES |
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Customer Tailored On-site Courses and Training Programs in the area of: |
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GMP and Compliance
Regulatory and Inspections
Leadership and Management
Technical and Manufacturing |
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