MILLBRIDGE PHARMACEUTICAL SCIENCE
Services
MillBridge Pharmaceutical Science offers a range of services either on
a stand-alone basis or in co-operation with one of its partners.
- We can assist in the preparation of a development strategy to
ensure that sufficient regulatory information is available in order to
submit an Investigational Medicinal Product Dossier (IMPD) or
Investigational New Drug Application (IND) in sufficient time for a
clinical trial.
- We can join your team to assist with problem solving during the development and regulatory process.
- The legal requirements for the import of pharmaceutical
products can be explained and the best process to comply with this
legislation can be determined for various potential scenarios, both clinical and
commercial.
- Non EU manufacturing and testing sites can be audited to ensure
compliance with EU requirements for Good Manufacturing Practice and
this can lead to the preparation of the GMP Declaration which is
submitted as part of the Clinical Trial Application.
- In the case of commercial products, the Active Pharmaceutical Ingredient (API) supplier can be audited.
- Arrangements can be made with fully authorised facilities in the
UK for import, packaging and distribution of a wide variety of product
types and under a range of temperature controls as appropriate.
- A fully equipped and authorised pharmaceutical analysis laboratory is available.
- There is access to a network of other QPs which extends the range of products and processes that can be assessed.
- One of our partner companies can assist with investigation into
poorly soluble compounds and physical characterisation of stabilised,
amorphous intermediates.