Chrai Associates
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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.
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  
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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

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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

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TECHNICAL 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
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Process Development
 

Technology Transfer

Package Development & Validation

Process Development & Validation

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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

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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

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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

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Outsourcing Programs
 

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
   
Customer Tailored On-site Courses and Training Programs in the area of:
 

GMP and Compliance

Regulatory and Inspections

Leadership and Management

Technical and Manufacturing

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