L O A D I N G
Global biotechnology company
Delivering innovative
healthcare solutions

Regulatory Strategy

  • Health Authority Briefing Packs
  • Scientific advice and Health Agency meetings

Preclinical Management

  • Development of GLP-standard preclinical study documents
  • Analysis of preclinical endpoints that will support the translation to the clinical development to build a case for higher reimbursement

Clinical Trials Services

  • Clinical Study Protocol Development and Review (Phase I – IV)
  • ICF writing and review
  • Clinical Study Report (CSR) Writing, Redaction and Review
  • Clinical Strategy development
  • Clinical Trial management
  • Orphan Drug Disease Strategy Development
  • Submissions and documentation
  • Development Gap analysis
  • GxP inspection support 

Product Development Consultancy

  • Strategy Support for Small and Medium Enterprises & Academic Groups
  • Drug indication planning
  • Build key decision makers and key opinion leaders network
  • Partnership and licensing opportunities
  • Analysis of best clinical development pathway to approval
  • Analysis of indications which present the best opportunities for your products
  • Scientific and Medical Writing
  • Drug repurposing

Our Development Cycle

Listen

Providing Health Sciences Consulting that meets your objectives starts with listening very carefully to your current and future objectives. The correct assessment at this stage is critical to delivering faster, better, smarter results for your organization.

Analyse

Once we’ve gathered all the relevant information our in-house experts can analyze your situation. Our team’s expertise in Clinical and Preclinical Development will analyze the state of development of your product, before the needs of the different markets.

Review

After thorough analysis, we’ll work with you to explore and discuss the most straightforward strategy to meet your objectives taking in consideration resources optimization and time to market.

Propose

Having shared and reviewed our analysis with you we’ll propose a solution to meet your requirements, a resource-optimized, market-oriented solution.

Implement

Once we’ve developed and agreed on the best strategic plan for your needs, we leverage our in-house capabilities, our external experts and our global vendor network to deliver on the execution.

Talk to us if you are interested

we would be extremely grateful to be able to help you.