Chrai Associates
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Suggy can you provide some introductory text here to introduce the section before we get to listing the services and their bullet points? It should be probably about 4-8 sentences.
 
Dosage Forms & API  I  Manufacturing Operations  I  Quality Management Systems & Control Programs  I  Process Validation & System Qualification  I  Facilities & System Design  I  Regulatory Affairs (CMC) & Audits  I  Business Management  I  Training  I  Product, Process, Program & Project (4P) Management
Dosage Forms & API
Development of Drug Delivery Systems - Controlled and Modified Releases, Liposomes, Aerosols and DPI; Transdermals
Process Development and Optimization for APIs
Formulation of Large and Small Molecules for Solid, Liquids, Semisolid and Sterile Products
Package Development including Container Closure Integrity
Stability Testing & Expiration Dating Programs for Product Specification
Intellectual Property Development and Management
Device Design and Improvements
Analytical Method Development and Validation
Pharmacokinetics & Pharmacodynamics
Bioavailability / Bioequivalence (IVIVC)
SUPAC
Preclinical and Clinical Programs
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Manufacturing Operations
Non-Sterile Products Manufacturing
Manufacturing of APIs
Trouble Shooting
Process and Equipment Design and Optimization
Process Development and Optimization for APIs
Manufacturing Operations and Controls
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Quality Management Systems & Control Programs
Document Preparation and Management
Laboratory Systems and Specifications
Method Transfer and Validation
Sampling Plans
Trend Analysis
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Process Validation & System Qualification
Validation Procedures and Protocols
Equipment & System Qualifications
Change Control Program
Computer Systems and Computer Controlled Operations
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Facilities & System Design
HVAC & Water Systems
Sterilization and Sanitary Requirements
Dust Control
Designing GMP and GLP requirements into Production, R&D, Laboratory & Pilot Facilities
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Regulatory Affairs (CMC) & Audits
International Regulatory Dossiers
Labeling
Product Recall Requirements
Performing GMPs, GLPs & GCPs for Audits:
· LVPs & SVPs
· Dosage Forms & API
· Diagnostics & Devices
Performing Quality and Control Change based:
· Application Verification
· Pre-Approval Inspection
· Due Diligence
Preparation of Regulatory Documents
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Business Management
Company and Product Acquisitions
Business Development Programs
Writing of Business Plans
Outsourcing Assessments
Due Diligence Audits for M&A
Benchmarking Studies
Providing Tools for Reducing Time & Cost
Productivity Analysis
Setting Performance Goals
Program and Project Management Controls
Intellectual Property Protection
Strategic Objectives & Alliances
Implementing Accountability & Performance Models
Implementing Customized Excellence Projects for R&D Excellence, Manufacturing
Excellence, QA Excellence
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Training
Overview of Regulatory Considerations
GMP Training in:
· Routine Manufacturing Operations
· Validation
· Documentation Control
· Sterile Product Production:
   · Clean Room Techniques
   · Personnel Practices
   · Sterilization
   · Lyophilization
   · Quality Control Laboratory
Technical Training
Leadership and Supervisory Training
In-House Trainging
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Product, Process, Program & Project (4P) Management
Product & Process Assessment
Technology Transfer from R&D to Marketing
R&D, Manufacturing and Quality Systems - Evaluation of Human Resource Requirements and Capabilities
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