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| Formulation and CMC
Development |
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H2 Pharma provides
extensive formulation and CMC development
support for new product development,
re-formulation and “PK re-profiling” to
enable new product opportunities.
We can manage the entire
formulation development programme (or parts
thereof) from the initial assessment of drug
delivery systems through to product
development, clinical testing and product
registration. We also provide up-to-date
knowledge and expertise of novel drug
delivery technologies thereby enabling our
Clients to create the most value for their
products. At every stage of formulation
development, we can assist with the
compilation regulatory CMC documentations
and support submissions globally.
Our expertise spans oral solid dosage forms,
modified release, combination products,
liquids, parenterals and topicals. We also
provide an extensive range of formulation
development resources to augment the
Client's development capability [see below].
Our services include: |
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Formulation
design, drug delivery technology
assessment and selection |
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Compilation of
formulation and process
nomination documents |
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Preparation of
regulatory CMC packages for CTA,
IND, MAA, NDA |
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Selection and
management CRO/CMO |
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Management of
process design, scale-up and
technology transfer |
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Management of
analytical and product stability
programme |
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H2 Pharma also provides a
unique range of formulation development
resources and proprietary teaching tools. We
can assist Clients with the provision of
hands-on formulation support via interim
deployment or management of in-house (or
external) formulation development
activities. In addition, we offer our
Clients with access to proprietary teaching
tools to enable expedited formulation
development, viz.: |
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"Plug-n-play"
composition for simple oral
solid dosage formulations |
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Technical
guidance on modified release
dosage form development |
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Development
approaches for combination
products |
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