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Regulatory support for 510K and CE mark process for a new laboratory standard

  • Regulatory services - CMC writing - medical writing
  • Human Medicines
  • Europe, North America

We need support to identify the requirements each of the sites involved in the manufacture, release and distribution of the standard must comply with for the step they are involved in the process. Later we may also need advice on the documentation ... More »

Levodopa-induced dyskinesia model in MPTP-marmosets

  • Pre-clinical development and testing, pre-clinical CRO
  • Human Medicines
  • Worldwide

We are looking for CRO's routinely performing levodopa-induced dyskinesia studies in MPTP-primed marmosets. Good experience with the model and reference data is a plus. More »

Clinical CRO with specialisation in oncology for Phase I in patients

  • Clinical development and testing, clinical CRO
  • Human Medicines
  • Europe

We look for a clinical CRO specialised in breast cancer. A neoadjuvant study design is planned to be used in a Phase I in postmenopausal patients with breast cancer (>T2). More »

Search for a global CRO that can devise a strategy of running a series of pediatric trials in the pain indication.

The CRO should take into consideration synergies and potential overlaps in terms of patient population age groups, indications, the benefit of using the same trial sites repeatedly or performing the trials in parallel. More »

Dossier for MICRONIZED PROGESTERONE

A global pharmaceutical company looking for a dossier for MICRONIZED PROGESTERONE. More »

Contract manufacturing and dossier for vaginal antiinfectives

Looking for Contract manufacturer and dossier for vaginal antiinfectives. If possible manufacturing site approved by Turkish regulatory authority (not a must). More »

Looking for provider with preclinical animal model for gynecological/urological infections

We are looking for an animal model to simulate human gynecological and/or urological indications as infections caused by e.g. Prevotella, Chlamydia, Mycoplasma or for indications as e.g. Bacterial Vaginosis, BPH, prostatitis in general. This could a... More »

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