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Clinpak’s expertise is delivered strategically, or operationally on a case-by -case basis as partner, advisor, or CMO and can start and stop at any point along your path to market, depending on your business model, resources and current stage of development.
A US based cosmetics company acquired a medial device portfolio for cosmetic use from
an overseas manufacturer and retained Clinpak to review and prepare the technical
package suitable for EU product marketing via PIF creation, Safety Study and CE
registration. This regulatory approach for such a product is complex given that th
product itself is not a pharmaceutical but is regarded under the regulations as a medical
Working with a virtual pharmaceutical company, Clinpak developed a portfolio
of products from formulation development through FDA approval and commercial
launch. The client identified the generic products it wish to bring to market and
Clinpak selected the API suppliers and designed the relevant formulation development
and regulatory strategy. Next Clinpak delivered manufactured development batches,
and all CMC data to be filed under ANDA, and managed the process validation program,
PAI activities and commercial launch on behalf of the client. The portfolio is a mix of
sterile injectables and solid oral dosage forms, and Clinpak still manages the commercial
supply post approval.
Clinpak acquired access to a range of injectable products approved outside the USA
from an approved CMO. The dossier were reviewed and remedial work performed to
bring each dossier up to ANDA requirements before filing. A US distribution partner
was identified for post approval marketing on a profit share basis.
VC based start-up approached Clinpak to develop initial formulations, and manufacturing
processes for their proposed range of liquid remedies. Clinpak selected active ingredients,
and developed formulations, in compliance with the OTC monograph. Clinpak also
developed and validated the manufacturing and fill-finish process, for commercial
launch, before executing a tech transfer to the large scale manufacturing partner.