Formulation and CMC Development
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:
► Formulation
design, drug delivery technology assessment and selection
►
Compilation of
formulation and process nomination documents
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Preparation of regulatory CMC packages for
CTA, IND, MAA, NDA
►
Selection and
management CRO/CMO
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Management of process
design, scale-up and technology transfer
►
Management of analytical and product
stability programme
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.:
►
"Plug-n-play" composition for simple oral solid
dosage formulations
► Technical guidance on
modified release dosage form development
►
Development
approaches for combination products