Our Services
CMC Drug Product
Consultancy
Uroboro Consulting offers expert guidance in the Chemistry, Manufacturing and Control (CMC) space with a focus on the design & development of oral and parenteral drug products at the preclinical and early clinical (Phase I-II) stages.
With Uroboro Consulting your project will be in safe hands. Its Founder, Dr Nicola Parisi (PhD), has a solid foundation of hands-on technical experience strengthened by subsequent roles as a CMC Drug Product Consultant for a diverse range of global Clients.
CMC Drug Product Consultancy activities include but are not limited to:
- Definition of Quality Target Product Profile (QTPP)
- Implementation of formulation strategies tailored to the QTPP and aimed at maximising the likelihood of progression to next stages
- Estimation of cost and time required for development activities
- Identification, selection and management of CROs / CDMOs suitable to the specific drug product attributes
- Interfacing with the broader CMC team and relevant stakeholders
- Navigating the complexities of developing drug products from Controlled Drugs with potential for abuse in the UK and US
Project Leadership
Uroboro Consulting’s Founder, Dr Nicola Parisi (PhD), is an established Project Leader who holds the Project Fundamentals Qualification (PFQ) from the Association for Project Management (APM).
Nicola has led numerous multi-disciplinary drug product development teams and enjoys the challenges which arise from fast-paced, technically complex projects.
Uroboro Consulting can support a plethora of Project Leadership activities including but not limited to:
- Creation of Gantt Charts to visualise and track project timelines
- Leading regular Project Team meetings to monitor project progression
- Coordination of Project Team activities using the Responsible, Accountable, Consult and Inform (RACI) matrix and Action Log to clarify roles and responsibilities of each team member
- Implementation of Quality Risk Management (QRM) tools as per ICH Q9 such as a Risk Register and Probability and Impact Matrix
- Summarising data and findings to the broader CMC Team and relevant stakeholders
Regulatory Submission
Uroboro Consulting’s Founder, Dr Nicola Parisi (PhD), has authored and reviewed multiple Phase I-II regulatory submissions for clinical trial authorisations in UK, EU, US and Australia. All of which have been approved with no questions received on the CMC Drug Product sections.
Therefore, Uroboro Consulting is ready to assist with your Regulatory Submission activities, including but not limited to:
- Authoring and reviewing of the quality and technical CMC Drug Product sections of Phase I-II regulatory dossiers
- Incorporating agile, pragmatic and phase-appropriate approaches to build in flexibility and minimise future submission amendments
- Updating of existing regulatory dossiers for submission in new territories
- Change control management including impact evaluation and preparation of required supporting documentation
- Due diligence and gap analysis assessment of existing data sets and documents to check suitability for Phase I-II regulatory submission
Patent Support
Uroboro Consulting is well placed to advise on your patent applications as its Founder, Dr Nicola Parisi (PhD), is a named inventor on several patents obtained through his work in the pharmaceutical industry.
Patent support activities include but are not limited to:
- Identifying potentially patentable drug product features from technical work or documentation related to your project
- Review of patent claims and specifications to ensure applications are scientifically sound
- Representing your project as a technical expert when interfacing with patent attorneys
- Fulfilling all documentation requirements for the submission of the patent and the waiving of personal rights to the invention