Regulatory advice and assistance

• Explanation of FDA and international regulatory expectations and policies
• Regulatory assessment and gap analysis
• Due diligence of potential investment opportunities
• Organization of meetings with regulatory agencies including FDA and European regulatory agencies
• Guidance on communication interactions with regulatory agencies
• Guidance on manufacturing and testing requirements
• Guidance on pharmacology and toxicology requirements
• Assistance in clinical trial design
• Management of regulatory operations for smaller biotech companies
• Management of regulatory project - major submissions

Regulatory submissions

• Preparation or review of regulatory submissions
• Pre-IND meetings or other meetings with regulatory agencies
• US clinical trial applications (IND)
• European clinical trial applications
• Australian clinical trial applications
• Other international applications
• Assistance in responding to FDA or regulatory agency questions
• Assistance in preparation of clinical trial amendments and annual reports
• Preparation of Orphan Drug Applications
• Preparation or review of Drug Master Files

Product development advice

• Preparation or review of product development plans
• Assistance with tech transfer of manufacture and test methods
• Review of manufacturing and pre-clinical information
• Project management

Contractor selection and management

• Identification of manufacturing or test laboratories
• Identification and assessment of experts or contractors
• Preparation of Requests for Proposals from contractors
• Review and assessment manufacturing and testing contractors
• GMP and GLP audits
• Negotiation with contractors on terms and conditions of contracts
• Monitoring of preclinical studies
• Review of batch and test records