Turio

• 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

• 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

Training

• Conducting on-site custom seminars on regulatory affairs issues and compliance issues
• Delivery of formal seminars and training conferences