Non-Clinical & Clinical Development Consultancy.
The right consulting advice and supporting services at every stage.
Arriello’s non-clinical and clinical development consultants and Subject Matter Experts (SMEs) can support you with a wide range of regulatory projects at all stages of product development, from first in human through to post approval.
We can provide specific expertise to integrate into your own development team, or we can support small/virtual biotech’s by providing a full team and the required regulatory project/programme management to facilitate the process.
Consultancy services and solutions typically include, but are not limited to, the following:
Review of existing data packages to advise on any potential gaps/risks and suggested mitigation strategies. This can be part of development planning or a due diligence exercise.
Development Plans & Target Product Profiles (TPPs).
Preparation or review of non-clinical and clinical development plans or TPPs for both internal use and or as plans to be endorsed by regulators. Our experts will advise on the likely studies needed, timescales and milestones.
Scientific Advice/Protocol Assistance/Agency Meetings.
- Preparation/Review of questions and company position statements.
- Preparation/Review of the relevant sections of the briefing book.
- Attendance and input at agency meetings including assistance with rehearsal planning.
Clinical Trial Applications (CTAs)/Investigational New Drug (IND) Applications.
Preparation/Review of the following:
- Protocol Synopsis/Protocol design.
- Investigator Brochures.
- Investigational Medicinal Product Dossiers.
- Relevant IND sections.
- Responses to grounds for non-acceptance/request for modification/agency deficiency letters.
Support with the following:
- Preparation for and attendance at pre-submission meetings.
- Review/Critique of Module 2 overviews and summaries.
- Participate in mock agency meetings/rehearsals.
- Preparation for and attendance at EMA SAG or Oral Explanation meetings.
- Preparation for and attendance at FDA advisory committee meetings.
In addition to the above our SMEs can also provide input and support with other agency submissions/interactions such as:
- FDA Breakthrough Designation requests.
- Orphan Drug Designations.
- Paediatric Investigation Plans.
- EMA PRIME submissions.
- Accelerated Assessment requests.
- EMA ATMP classification requests.
The expert or team assigned to your project will be specific to your particular requirements and with the relevant specific product expertise applicable (e.g. ATMP products).
What our clients say about us.
Arriello has highly knowledgeable staff in all countries with a very professional attitude. They are very fast in responding when needed.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.