Product Development & Technology Transfer

Key Areas We Can Support

Depending on project scope, MGS may support:

• Product-development planning
• Formulation-development coordination
• Process-flow development
• Critical Quality Attribute identification
• Critical Process Parameter assessment
• Material attribute assessment
• Risk assessment
• Equipment suitability
• Batch-size considerations
• Scale-up strategy
• Process optimization
• Hold-time considerations
• Cleaning considerations
• Analytical requirements
• Sampling strategy
• Process capability
• Technical troubleshooting
• Technology-transfer planning
• Site-readiness assessment
• Knowledge-transfer documentation
• Validation interface
• Regulatory documentation interface

Technology Transfer Support

A structured technology transfer helps ensure that product and process knowledge is accurately transferred from the sending unit to the receiving unit. MGS can support activities such as:

• Transfer planning
• Scope definition
• Responsibility assignment
• Product and process knowledge review
• Manufacturing-process assessment
• Equipment comparison
• Facility and utility assessment
• Analytical-method transfer coordination
• Material assessment
• Batch-size evaluation
• Critical parameter review
• Risk assessment
• Training
• Trial or engineering batch support
• Process-validation interface
• Documentation review
• Transfer completion assessment

Scale-Up & Process Optimization

During scale-up or process improvement, MGS may support evaluation of:

• Equipment differences
• Mixing and blending conditions
• Processing times
• Temperature
• Pressure
• Flow
• Drying parameters
• Compression parameters
• Coating parameters
• Filling parameters
• Yield
• Hold times
• Process variability
• In-process controls
• Critical parameters
• Product quality trends
• Commercial manufacturability

Our Approach

1. Understand

Review the product, formulation, process, development history, equipment, analytical requirements, and project objectives.

2. Assess Risk

Identify technical, process, quality, scale-up, transfer, and manufacturing risks.

3. Define the Strategy

Establish development, optimization, scale-up, or technology-transfer activities, responsibilities, timelines, and documentation requirements.

4. Execute

Support technical activities, process evaluation, trial batches, transfer coordination, troubleshooting, and documentation.

5. Evaluate

Review results, process performance, deviations, trends, equipment suitability, and product-quality outcomes.

6. Transfer & Sustain

Support knowledge transfer, documentation closeout, validation interface, and ongoing process improvement where required.

Typical Deliverables

Depending on scope, MGS can provide:

• Product-development plan
• Process-development support
• Development risk assessment
• Critical parameter matrix
• Scale-up strategy
• Process optimization recommendations
• Technology-transfer plan
• Technology-transfer protocol
• Responsibility matrix
• Site-readiness assessment
• Equipment comparison
• Process-gap assessment
• Technical troubleshooting report
• Development report
• Transfer report
• Process knowledge package
• Technical documentation support

Why Choose MGS

Development-to-Manufacturing Perspective

MGS focuses on practical translation of product and process knowledge into scalable and manufacturable operations.

Risk-Based Technical Support

Development and transfer activities are prioritized according to their potential impact on quality, process performance, and successful commercialization.

Cross-Functional Integration

Our approach can integrate formulation, manufacturing, engineering, validation, quality, analytical, and regulatory considerations.

Practical Technology Transfer

MGS helps structure the transfer of knowledge, responsibilities, process parameters, documentation, and technical requirements between sites or organizations.

Flexible Support Model

Support can be provided for selected development activities, complete technology-transfer projects, process optimization, or troubleshooting assignments.

Who We Support

MGS can provide Product Development & Technology Transfer support for:

• Pharmaceutical manufacturers
• API manufacturers
• Finished dosage form companies
• Biopharmaceutical organizations
• Contract manufacturers
• Product-development organizations
• Technology licensors and licensees
• Organizations transferring products between sites
• Companies scaling up new products
• Facilities optimizing or remediating existing processes