Partnership Services
Jean Vichar supports contract manufacturing and development programs across solid dosage forms, metered dose inhalers and nasal sprays, with dry powder inhaler expertise available through Lirok Pharma.
REF. JV-CDMO-001ENGAGEMENT MODEL
The right model depends on the maturity of the product, the quality of the available technical package and the work required before routine commercial production.
For an established product, Jean Vichar can assess the existing process, analytical methods, material specifications, packaging configuration and supply expectations before defining a contract manufacturing pathway. Where formulation, process adaptation, device integration, scale-up or registration support is still required, the engagement can include development activities in addition to manufacturing.
Every opportunity begins with technical and quality review. Scope, responsibilities, documentation, timelines and decision points are agreed before execution begins.
REF. JV-SCOPE-002SERVICE SCOPE
For products with an established formulation, process and technical package that require transfer into an appropriate manufacturing platform.
For products that require additional technical work before a stable, transferable and commercially viable process can be established.
REF. JV-JOURNEY-003PARTNERSHIP JOURNEY
Clarify the product, intended market, technical package, target volumes and commercial objectives.
Review or develop the composition, dosage form, delivery system and critical product attributes.
Adapt the process to available equipment and establish appropriate operating ranges and controls.
Plan the evidence required to demonstrate repeatable performance of methods, cleaning and production processes.
Support the manufacturing and technical information required for the agreed registration pathway.
Execute approved batch records and controls within the established quality framework.
Coordinate components, artwork, coding and pack configuration for the intended market.
Where appropriate, coordinate domestic delivery through Ti-One and the wider pharmaceutical ecosystem.
REF. JV-TRANSFER-004TECHNOLOGY TRANSFER
A successful transfer requires enough information to understand why the process works, where it is sensitive and how quality is demonstrated. Jean Vichar reviews the available development history, master formula, process description, material attributes, analytical methods, stability information, packaging system and previous manufacturing experience.
Open questions are converted into a documented work plan. Trials, engineering batches and validation activities are then used to confirm that the process is suitable for the selected platform.
REF. JV-GOV-005PROJECT GOVERNANCE
The quality agreement and project plan should distinguish responsibilities for specifications, methods, materials, change control, deviations, release, regulatory communication and market supply.
Technical decisions, assumptions, risks and approvals are documented so that both organizations understand what must happen before the next stage begins.
Initial inquiries should avoid unnecessary confidential formulation details. Appropriate confidentiality arrangements can be established before detailed technical exchange.
Commercial manufacture requires ongoing review of changes, supply risks, performance trends and opportunities to improve reliability.
Our team can review the available information and identify the most appropriate technical and commercial pathway.
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