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The Pleiad Europe team has extensive medical biotechnology and
pharmaceutical regulatory and development experience and is skilled
at resolving the issues that innovative companies face. We have
experience of working with new chemical and biological entities
as well as generics, herbals, functional foods, drug-device combinations
and borderline substances.
Commissions usually begin with a meeting between the potential
client company and Pleiad at which any issues and the ways in which
Pleiad might assist are explored. There is no charge for this meeting.
A detailed work plan with appropriate milestones, fees and expense
budget is then agreed and work commences. Fees are either based
on a daily rate consultancy charge or on a fee-for-service basis.
Successful product development and commercialisation provide the
focus for the services provided by Pleiad Europe to therapeutic
companies:
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Of particular interest to European clients might be the services
that the Pleiad group offers in the USA such as:
- Management of clinical trials in the USA including the attendant
regulatory documentation.
- “Reality checks” on development programmes initially
designed for Europe. This includes an assessment of the regulatory
acceptability, the clinical feasibility and the suitability of
the programme for the US market, taking into account the different
healthcare system and regulatory expectations in the USA compared
to Europe.
- Negotiation with the FDA at programme design, clinical trial
and dossier submission stages (pre-IND, end-of-Phase II and pre-NDA
stages).
- Explanation of, guidance through and management of the IND and
NDA/BLA approval systems in the USA.
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