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PharmaSol's Services
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Feasibility Studies
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PharmaSol performs feasibility studies that allow its customers the opportunity
to assess whether the PharmaSol solubility enhancing technology is suited to their respective formulation need.
PharmaSol provides consultancy free of charge for the delivery problem of the customer. A
formulation approach is suggested in cases where PharmaSol technologies can be applied. If the customer decides to go ahead
with the next step, PharmaSol will provide a detailed work program including a cost calculation. A
nominal fee is charged for this, but it is fully deductible if the feasibility study is carried out by PharmaSol.
Certain milestones are defined within the feasibility study, including GO/NO GO decisions. PharmaSol
will provide written reports and updates by phone or email during the study. At the end of the feasibility
study, a summary report containing data sheets will be provided and a suggestion for the development
of the final optimised formulation.
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Formulation Development
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After successful completion of a feasibility study, the customer can decide whether to go ahead with formulation development
independently or to allow PharmaSol to continue partially or completely with the development. PharmaSol will put together a tailor-made
offer that considers the specific needs of each customer and which is simultaneously the most effective in reducing the
development time.
In general, a formulation development contract will be established between the customer and PharmaSol.
A detailed research program, which includes a cost calculation, will be put together and will be attached
as an appendix to the development contract. The development program will once again contain milestones and GO/NO GO
decisions. Written reports will be provided during the development work as well as
updates by phone or email during the study. A final report will be supplied at the end of the development
work. The documentation during the development work will be performed according to the SOPs of the customer.
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Option Agreement
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PharmaSol customers have the choice between having a feasibility study with PharmaSol without any
further agreements or commitments, or alternatively, the feasibility study can be accompanied by a signed
option agreement. Within this option agreement, PharmaSol reserves exclusively the
technology rights respective to the drug/drug class of the customer during the conduct of the
feasibility study, plus sufficient additional time for decision making after the completion
of the study. The option agreement also defines rough licensing conditions in case
the customer desires to license the PharmaSol technology for their drug and to go ahead with a
final licensing agreement. For the reservation of the technology, a license fee will be charged
by PharmaSol, which is of course fully deductible in cases where a final license agreement is established.
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Technology Transfer
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After the completion of the formulation development and/or the conclusion of the licensing contract,
PharmaSol offers the service of a full technology transfer to the customer/licensee. The
customer can choose from an array of different services within this technology transfer. Examples
are training of staff in the PharmaSol laboratories, training of staff at the customerīs site,
theoretical seminars about the transfer process, validation of the transfer process
by comparative production of batches at PharmaSol and at the customerīs site, provision of
scientific literature and PharmaSolīs internal information regarding the technology.
A separate technology transfer agreement will be established between the customer and PharmaSol
describing in detail the different steps within this technology transfer.
Apart from the pure technology transfer, PharmaSol also offers the possibility of entering into a subsequent
consultancy arrangement to provide the customer with exclusive assistance for as long as requested.
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