BESPONSA® is an intravenous infusion indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
Turio was established in 2004 and is an international consulting company for the pharmaceutical industry, based in London, UK. The company offers a comprehensive range of scientific, technical, regulatory and management services to pharmaceutical, biotech and private investing companies.
Advice and support is provided by a team of core independent consultants, recognised experts in their field. They collectively have several decades of scientific and regulatory experience in the pharmaceutical, biotech and national agencies within EU and US FDA. The highly qualified team is assisted by a network of professionals which cover all areas of pharmaceutical and biotechnology expertise.
Our experts have been particularly successful in assisting clients in Central Eastern European and Asian countries, the EU, as well as the US.
Examples of completed projects:
- Pre-clinical development to IND submission of a lead candidate in oncology
- Complex products (long release parenterals) and biosimilars development on behalf of a large generic company
- Evaluation of in-licensing opportunities on behalf of big pharmaceutical and generic companies
- M&A due diligence audits – technical, regulatory, compliance
- cGMP audits, mock PAI (pre-approval inspections) and advice in responding to FDA 483 observations and EU inspection deficiencies provided by ex-FDA and MHRA inspectors
- Regulatory strategy and support from early phases of drug discovery to approval for marketing, scientific advice and assistance with pre-submission meetings with EMEA and FDA
- Project management of complex products development
Turio project management for pharmaceutical and biotech companies
- Scientific, technical and strategic project management from early drug discovery up to marketing
- Bridging between the client’s internal teams and outsourcing organisations
- Drawing up formal project plans with resource allocation and cash flow analysis
- Design of suitable studies and protocol preparation
Strategic regulatory consulting
Turio offer a strategic regulatory consulting service providing advice on appropriate regulatory strategy, recommending the best route to the market and preparation of briefing packages for pre-submission meetings with EMEA and FDA
Turio can also assist with preparation and compilation of CTD and submission to RA authorities worldwide, including, US, EU and other national agencies. Turio offer expert report authoring of pharmaceuticals and pre-clinical modules.
The service also offers assistance in communicating with national agencies and preparing for RA meetings with agency officials on application issues.
- Due diligence audits and assessments for M&A, licensing activities and company / product evaluation
- Portfolio evaluation of target companies
- Product development assessment and advice
- Regulatory affairs evaluation – dossier assessment and gap analysis
- Regulatory strategy for product roll-out in international markets
Audits and compliance for M&A or in-licensing / supply activities
- Compliance audits to assist M&A or in-licensing / supply activities (cGMP, GLP) conducted worldwide by former FDA and MHRA inspectors
- Pre-approval inspection readiness (EMEA and FDA cGMP guidelines)
- Preparation of responses to FDA 483 citations or EU inspections reports
- Conducting on-site custom seminars on regulatory affairs issues and compliance issues
- Delivery of formal seminars and training conferences