DSI develops a well-defined project plan for companies so that they can confidently navigate the pharmaceutical research and design and regulatory process and easily track their progress.
CMC DevPlan™
DSI develops a management tool for planning, costing, and resource purposes and allows companies to track their progress against a well defined project plan. It is a comprehensive, static Gantt Chart in MS Project format.
CMC DevTrak™
DSI specifically develops a comprehensive, interactive Gantt Chart in MS Project format with links between events as they would happen in real time allowing companies to determine affects of development delays, setbacks, and accelerated pathways. Through this service, the customer is able to explore simulations to the plan and see how changes effect the timing of product development.
CMC DevCost™
CMC DevCost provides a further step up from the listed outputs of CMCTrak™ by adding costing and resource requirements to the plan . It is a comprehensive, interactive Gantt Chart in MS Project format with links between events as they would happen in real time allowing companies to determine affects of development delays, setbacks, accelerated pathways as well as their effects on budgets, resources and COG’s.
| Items covered in GANTT: | CMC DevPlan | CMC DevTrak™ | CMC DevCost | |
|---|---|---|---|---|
| API characterization and Polymorph/impurity/purge studies | ||||
| API characterization and Polymorph/impurity/purge studies | ✓ | ✓ | ✓ | |
| API process development, scale up and Validation | ||||
| API process development, scale up and Validation | ✓ | ✓ | ✓ | |
| DP characterization | ||||
| DP characterization | ✓ | ✓ | ✓ | |
| DP formulation, process development, scale up and Validation | ||||
| DP formulation, process development, scale up and Validation | ✓ | ✓ | ✓ | |
| Raw material, Intermediates and Primary packaging materials sourcing,qualification, purchase and release | ||||
| Raw material, Intermediates and Primary packaging materials sourcing,qualification, purchase and release | ✓ | ✓ | ✓ | |
| Pre-and clinical trial material manufacture, engineering batches | ||||
| Pre-and clinical trial material manufacture, engineering batches | ✓ | ✓ | ✓ | |
| Method development, optimization and validations | ||||
| Method development, optimization and validations | ✓ | ✓ | ✓ | |
| Reference standards establishment, supply and qualification | ||||
| Reference standards establishment, supply and qualification | ✓ | ✓ | ✓ | |
| ICH registration and supporting stability studies, cycling, light | ||||
| ICH registration and supporting stability studies, cycling, light, | ✓ | ✓ | ✓ | |
| Forced degradation studies | ||||
| Forced degradation studies | ✓ | ✓ | ✓ | |
| Registration batches API and DP | ||||
| Registration batches API and DP | ✓ | ✓ | ✓ | |
| Development reports, IND and NDA filing timings | ||||
| Development reports, IND and NDA filing timings | ✓ | ✓ | ✓ | |
| The GANTT will be linked by predecessor and successor and will be linked backwards form NDA filing. Clients with MS project proficiency will be able to determine effect of changes in event timing acceleration or delays on the project . | ||||
| The GANTT will be linked by predecessor and successor and will be linked backwards form NDA filing. Clients with MS project proficiency will be able to determine effect of changes in event timing acceleration or delays on the project. | ✕* | ✓ | ✓ | |
| Small SME interaction internally to assure logic behind GANTT is correct | ||||
| Small SME interaction internally to assure logic behind GANTT is correct | ✕ | ✓ | ✓ | |
| The GANTT will be populated with costs either obtained by client or estimated by DSI for all major events in the plan. If project requires resources that drive event timing those will be included. | ||||
| The GANTT will be populated with costs either obtained by client or estimated by DSI for all major events in the plan. If project requires resources that drive event timing those will be included. | ✕ | ✕ | ✓ | |
| Small SME interaction internally to provide general budget cost and timing estimates for events | ||||
| Small SME interaction internally to provide general budget cost and timing estimates for events | ✕ | ✕ | ✓ | |
| Cost | ||||
| Cost | Contact Us | |||
*The GANTT will be static in that events are not linked by predecessor and successor.
OUT OF SCOPE
- Management of all product development activities
- Ongoing running of timeline
- SME interaction with client or strategic advice
- Development of budget outside of that within GANTT (CMC DevCost)