The industrial structure of pharmaceutical and medical device development and production have changed from a vertically integrated type, in which one company is involved all the way from the search for developed products to a regulatory application, to a flat collaborative type, in which each process is outsourced.
In order to speed up and improve R&D, outsourcing to a more appropriate and reliable external organization is highly effective.
Our staff, who have gained expert knowledge and experience through their respective operations, will provide professional services that will assist you in achieving your company’s goals.
Procedures up to outsourcing:
Intermediacy of outsourcing services for R&D and manufacturing of Pharmaceuticals, medical devices and functional foods.
The following is an example of an outsourcing procedure, but adjustments can be made based on a client’s request.
1. Conclude a non-disclosure agreement:
Between two or three parties.
2. Present outline of outsourcing projects:
LMed experts meet the client to confirm the requests and transfer the project to the most appropriate contractor.
3. Clients visit the selected contractor:
Inspect the facilities and work out concrete details for the project. (In the case a client does not want to visit the facility, the details of the project will be shared by other means.)
4. Proposal of outsourcing contract and project plan:
When an agreement is reached regarding the content of the outsourced work, the contractor will propose the business plan in a Master Service Agreement and its addendum to present specific project period, cost, payment method, etc.
5. Conclude an outsourcing contract:
If a final agreement is reached between the client and the contractor, a contract will be signed, and the contract work will commence.
6. Project management support service:
LMed will support communication between sponsors and client until the project is completed, if necessary, even after the contract period has expired.