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 critical aspects of drug development.

1

Development strategy

2

Operational project management of non-clinical tasks

3

Clinical trial oversight

4

Quality assurance

5

Regulatory affairs

Development strategy

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

OUR SERVICES INCLUDE
  • Defining target product profiles (TPPs)
  • Gap-fill analysis of CMC/production and non-clinical data packages and/or of existing development plans
  • Establishing an optimised regulatory strategy covering all non-clinical aspects of development, including CMC, pharmacology, pharmacokinetics and toxicology
  • Defining customised, regulatory-compliant development plans, complete with timelines, budget estimates and risk assessments

Operational project management

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

OUR SERVICES INCLUDE
  • Identifying appropriate CROs for your pharmacology, pharmacokinetics and/or toxicology studies, including bioanalytical method development and validation
  • Identifying appropriate CMOs for the manufacture of your drug substance(s) and drug product
  • Preparing and submitting detailed request for proposals
  • Providing recommendations for CRO/CMO selection
  • Qualifying CROs/CMOs through quality 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

Clinical trial oversight

We will help select the most appropriate clinical service providers, and will manage and coordinate their activities to ensure successful implementation and completion of your clinical trial.

Our services include
  • Identifying relevant clinical vendors
  • Preparing and submitting detailed request for proposals
  • Providing recommendations for clinical vendor selection
  • Ensuring QMS and GCP compliance through on-site audits of clinical vendors
  • Continuous centralised monitoring and coordination of clinical vendors
  • Regular reporting to management or to the board of directors

Quality assurance

We will perform quality (GMP, GLP, GCP, ISO) audits of your service providers, including:
  • Preparation of the audit and audit agenda
  • Onsite audit of the CMOs/CROs
  • Generation of an audit report
  • Follow-up with the CMOs/CROs to agree on a corrective action plan to address observations raised in the audit report
We also offer:
  • Development, implementation and maintenance of quality systems
  • Auditing of internal quality systems
  • QA training

Regulatory affairs

We will write key regulatory documents for your applications:
  • The Investigator’s Brochure (IB)
  • The Investigational Medicinal Product Dossier (IMPD)
  • The Investigational New Drug application (IND)
  • The briefing book/package for meetings with authorities
  • Orphan Drug Designation (ODD) applications
  • Common Technical Document (CTD) sections for registration applications
And can help you finalise:
  • The clinical study protocol
  • The patient information leaflet
  • The Informed Consent Form
We will also:
  • Organise and participate in meetings with national competent authorities, the EMA and the FDA, such as scientific advice, pre-IND, end-of-phase-2 meetings, etc.
  • Obtain EMA/FDA product classification