SERVICES
We offer the below given services (Onsite and Offsite) to help you resolve any of your problems in the below given areas with Project Management, hand holding and documentation for any category and dosage form (Pharmaceuticals (API, OSD, Liquid Orals, MDI/DPI, SVP, LVP, Parentals, Sterile Dosage Forms etc), Nutraceuticals, Food etc for any regulated market like US, EU, MEA, Africa, Asia ,Latin America etc.
Formulation
R&D
Analytical
R&D
Green Field Project Implementations
Audits, Remediation & Compliance
Process Automations
with Computer System Validation
Trainings on
any topic
Regulatory Affairs
Research & Development
- Formulation development
- New Products Development
- Scale up Studies
- Quality by Design Planning
- Manufacturing and Analytical Technology Transfer
- Execution of Submission Batches
- Execution of Commercial Batches
- Regulatory queries response & remediation
- Reverse Engineering
- Stability and Photostability Studies
- Process Optimization and Automation
- Analytical Tech transfers
- Equivalency Studies
- Analytical method development & validation
- Excipient Compatibility Studies
- Impurity Profiling of Drug substances and products
- Leachable and Extractable
Audits, Remediation & Compliance
- GxP Audits: Gap analysis and remediation with Project Management with complete documentation
- Remediation of Inspection Observations with documentation
- All Time Readiness: Gap analysis and remediation with Project Management with complete documentation
- Data Integrity audits and remediation
Green Field Project Implementations
- Green Field Project Implementation with Qualification & Validations, Project Management with complete documentation
- cGMP systems & Procedures updation & enhancement
- Process Streamlining, Optimisation, Simplification & Efficiency Improvement
Formulation R&D
Project Management, Handholding and Complete Documentation for
- Formulation development
- New Product Development
- Scale up Studies
- Quality by Design Planning/Guidance
- Manufacturing Technology Transfer
- Planning/Guidance for execution of Submission batches and Commercial Batches
GMP Gap Analysis
- Planning/Guidance for execution of Submission batches and Commercial Batches
- GxP Audits : Gap analysis and remediation with Project Management and documentation.
- All Time Readiness: Gap analysis and remediation with Project Management and documentation.
- Inspection Observations : Drafting of Response and Remediation and closure of Inspection Observations with documentation.
- Data integrity : Data Integrity audits and remediation
Process Automations
with Computer System Validation
- SAP or any ERP software
- Quality Management System
- Document Management System
- Stability Management
- Artwork Management
- Laboratory Information Management System
- Training Management
- Pharmacovigilance Software
- Clinical Data Software
- Regulatory Information Management System
- Electronic Document Archival
- Electronic Regulatory Submissions
- CFR 21 Part 11 and Annex 11 assessment and remediation
- Data Integrity Evaluation and Remediation
- Any other automation that is required.
Analytical R&D
Project Management, Handholding with Documentation for
- Analytical Method Development and Validation Studies
- Excipient Compatibility Studies
- Impurity Profiling of Drug substances and Drug products.
- Extractables and Leachable study
- Reverse Engineering
- Stability and Photostability Studies
- Process Optimization and Automation
- Analytical Tech transfers
- Analytical Method Equivalency Studies
Manufacturing Plant Establishment
- Distribution of Pharmaceuticals, Biologicals and Medical Devices across the world.
Trainings on any topic
- Formulation Development
- Quality by Design
- Analytical Method Development
- Analytical Method Validation
- Good Warehouse Practices
- Good Production Practices
- Good Laboratory Practices
- Good Distribution Practices
- Good Quality Practices
- Good Documentation Practices
- Quality Management System
- Life Cycle Computer System Validation for Cat 3,Cat 4 and Cat 5 softwares
- Data Integrity Evaluation
- Any Other Training as required
Regulatory Affairs
Regulatory Submissions :
- Compilation and review of dossiers for US,EU ,PIC/S and ROW markets for Drug Substance and Drug Product.
- Resolving Regulatory queries