CNS’ BioDesk is an expert consulting team offering CMC/manufacturing, toxicology, clinical/medical and regulatory affairs consulting services for readying products to enter clinical trials or marketing approval.

BioDesk Core Services Include:

Click on the service titles below to view details:

BioDeskServices

  • Generation of a clinical development strategy to support a global development approach
  • Full protocol development including study design, appropriate clinical endpoints, inclusion / exclusion criteria, and sample size calculations
  • Feasibility assessments – where to undertake the study based upon key selection criteria

  • Generation of a non-clinical development strategy to support a global development approach
  • Non-clinical study design including protocol development
  • Vendor selection and management including GLP auditing services

  • Support on understanding the CMC data that would be required to support a global development approach
  • Technical CMC input including but not limited to manufacturing process development and validation, product characterisation, assay development, advice on specifications and stability programmes
  • Vendor selection and management including technical review of manufacturing plans and GMP auditing

  • Development of a Drug Development Plan (DDP) covering CMC, non-clinical and clinical aspects from early stage of development to approval
  • Developing a forward looking Target Product Profile (TPP) that will streamline and focus development
  • Detailed planning with regards to specific aspects of CMC development, non-clinical development and clinical development

  • Generation of activity specific Request for Proposal (RFP) document and management of the vendor identification / selection process
  • Critical evaluation of vendor proposals including auditing services (GXP)
  • Ongoing vendor management to ensure successful completion of the contracted activities

  • Integrating opportunities in the regulatory framework to add value to your corporate goals and reduce time to market
  • Preparing for due diligence: Integration of development, regulatory and corporate milestones
  • CNS’ strategic partners such as Ventac Partners, can also assist in tailoring company commercial/business plans to meet investor expectations

  • Development of a global regulatory strategy to guide a product from early development all the way through to approval
  • Understanding the route to market in key regulatory regions and the options available for your product
  • Opportunities in the regulatory framework to add value to your corporate goals and reduce time to market

  • Expert CMC advice to support the resolving of complex CMC / quality related issues associated with the manufacture of the product
  • Assessing the impact of issues identified in the non-clinical development of a product and what the appropriate next steps are
  • Clinical strategy input in the study design area or in the analysis / interpretation of the data generated from a clinical study

  • Preparation of the core documents including protocol, Investigator Brochure (IB), Investigational Medicinal Product Dossier (IMPD), INDs, CTX and CTNs
  • Full authoring from raw data of the MAA Modules 1 – 5 including preparation and official sign off of the expert assessments including in Module 2
  • Writing all types of regulatory documents including those for: pre-INDs , Scientific Advice, Orphan Drug Designations (ODDs) Paediatric Investigational Plans (PIPs)

  • Our programme / project management services are focussed on getting client’s products ready for the clinic or regulatory approval as efficiently and cost effectively as possible
  • Programme / project management activities can be all inclusive (manufacturing / quality, non-clinical development and clinical development) or just a specific element that requires additional expertise/resource (e.g. specific nonclinical model or a specific assay development activity)
  • Activities include the generation of project plans, timeline charting, and implementing document / version tracking systems. Ongoing project management is provided on an ad hoc basis, as required

  • Agency  interactions associated with clinical trial studies including pre-CTA meetings in Europe and pre-IND meetings in the US for example
  • Preparation of the core documents including protocol, Investigator Brochure (IB), Investigational Medicinal Product Dossier (IMPD), INDs, CTX and CTNs
  • Preparation of regional/country information and all submission related activities

 

  • Regulatory activities associated with the paediatric development including the development of a paediatric strategy and the preparation and submission of Paediatric Investigation Plans (PIPs)
  • Preparation and submission of Orphan Drug Designation (ODD) applications in Australia, USA and the EU
  • CNS is a full service regulatory group able to support any additional regulatory activities and procedures not mentioned on our website. This email address is being protected from spambots. You need JavaScript enabled to view it.to discuss your requirements

 

  • Full protocol development – clinical or non-clinical studies
  • Authoring of Clinical Study Reports (CSRs)
  • Writing all types of regulatory documents including those for: pre-INDs, INDs, CTAs (IBs and IMPDs), Orphan Drug Designations (ODDs) Paediatric Investigational Plans (PIPs), through to Marketing Authorisation Applications (MAAs) and everything in between

  • Co-ordinating and attending meetings or teleconferences with selected regulatory agency / authority
  • Generation of the required briefing document including the list of questions and accompanying company position
  • Ensuring the interactions add value to the clients corporate and development strategy

 

  • Expert review and revision of a MAA – problem identification and solution generation
  • Preparation of skeleton MAA CTD for company population as well as continued guidance through the MAA generation
  • Full authoring from raw data of the MAA Modules 1 – 5 including preparation and official sign off of the expert assessments including in Module 2