These are a few examples of recent projects which we have been involved with and is not an exhaustive list of services available:
  • Preparation of Type II Variations including m2-3-p for a new API source for a group of X-ray contrast media (UK national and MRP).
  • Preparation of Type II Batch Specific Variations including m2-3-p relating to shelf life reductions for an oral tablet product (UK national).
  • Preparation of Type II Batch Specific Variations including m2-3-p relating to packaging changes for an enema product (UK national).
  • Preparation of Type II Variations including m2-3-p relating to particle size changes in the API for an X-ray contrast medium (multiple national variations).
  • Project managing & submitting MA transfers for a group of 70+ MA’s (+ associated variations & labelling changes) in UK, IE, FR, ES, DK, FI and SE.
  • Audit of potential generic product dossiers (topical product) from a contract manufacturer in France.
  • Audit of potential generic product dossiers (injectable and solid-dose) from a contract manufacturer in North Africa.
  • eCTD Training Course for a UK client.
  • Clinical Evaluation Reports for multiple Medical Devices (Classes I to III).
  • Cosmetic Safety Assessments for several products.
  • Preparation of m2-4 and m4 for an application for an injectable painkiller in North Africa.
  • Preparation of m2-4, m2-5, m4 and m5 for an application for a novel presentation of an injectable anti-inflammatory in France.
  • Preparation of m2-4, m2-5, m4 and m5 for an application for a generic MRI contrast agent for the EU
  • Preparation of m2-5, m2-7 and m5 for an ‘old’ diagnostic radiopharmaceutical product in order to enable new submissions outside the EU.
  • Response to DCP questions relating to justification for non-submission of a Clinical or a Bioequivalence Study for an oral capsule product.
  • Review of published literature to obtain pharmacokinetic data & design a Bioequivalence Study for an oral capsule product.
  • Review of published literature to assess feasibility of a bibiographical application for an oral solution.
  • Provision of advice on regulatory strategy for a multi-strength oral tablet product to a Canadian generics manufacturer.
  • Preparation of a report on advertising of medicinal products in the UK for a major wholesaler.
  • Preparation of a report on the specific national ‘blue box’ requirements for a number of EU member states for a Japanese client.