Our non-clinical development expertise will help you rapidly build company value from your innovations, surpassing your investors’ expectations.

Taking the role of both the architect and the construction manager in building your project, we will draw up the designs and plans, recommend the best contractors and then manage and co-ordinate the work through to its completion.

We provide expert advice, guidance and hands-on support for your innovative products concerning three critical aspects of drug development.

1

Development plan design

2

Operational project management of non-clinical tasks

3

Regulatory submissions and communication with the competent authorities

Development plan design

We guide you through all stages and all aspects of non-clinical development design to produce a fully optimised plan. Our reverse planning approach ensures that your plan is tailored to your clinical development and company objectives.

OUR SERVICES INCLUDE
  • Defining the target product profile (TPP)
  • Gap analysis
  • Establishing a regulatory strategy
  • Defining a customised, regulatory compliant development plan, complete with timelines, budget and risk assessment

Operational project management

We provide professional and flexible operational project management to ensure the efficient implementation of your customised / global development plan. We will help select the best service providers, and then coordinate and manage their activities.

OUR SERVICES INCLUDE
  • Identifying and recommending appropriate CROs and CMOs
  • Preparing and submitting detailed proposal requests
  • Qualifying CROs/CMOs through audits
  • Protocol/work plan design
  • Continuous monitoring and coordination of CROs/CMOs
  • Editing study reports and reviewing documentation to ensure regulatory compliance
  • Regular reporting to Management or to the Board of Directors

Regulatory support & submissions

We will write key regulatory documents for your clinical trial applications:
  • The Investigator’s Brochure (IB)
  • The Investigational Medicinal Product Dossier (IMPD)
  • The Investigational New Drug (IND)
And can help you finalise:
  • The Clinical Trial Protocol
  • The Patient Information Leaflet
  • The Informed Consent Form
We will also:
  • Organise and participate in scientific advice and pre-IND meetings with national competent authorities, the EMA and the FDA.
  • Identify relevant clinical centres, investigators and/or key opinion leaders
  • Recommend clinical CROs
  • Write Orphan Drug Designation applications
  • Obtain EMA/FDA product classification
  • Write NDA, BLA, MAA

Working with us

THE BENEFITS TO OUR CUSTOMERS INCLUDE
  • Immediate access to a fully operational team of development experts
  • A realistic and practical hands-on approach
  • Reduced project risk & optimised project outcome
  • Rapid progress to clinical milestones, creating tangible company value
  • Full transparency, flexibility and reactivity