Consultancy Services 
 
Strategic Clinical-Regulatory Development and FDA Liaison 

• Guidance in clinical-regulatory strategy development
• Critical regulatory review of clinical documents
• Preparation for FDA meetings: Pre-IND, EOP2, Pre-NDA/BLA
• Negotiations with FDA including dispute resolutions
• Strategic advice with FDA advisory committee meetings

Strategic CMC-Regulatory Development and FDA Liaison

• Critical review of CMC documents for drugs, biologicals and devices
• Strategy development for drug-device combination products
• Guidance with the Quality Systems Regulations for devices
• Development of the Drug Master Files
• Preparation for FDA meetings on technical CMC and device issues

Electronic Dossier Compilation and Submission 

• Development of a US and/or Global eCTD strategy
• Compilation and submission of eINDs and eCTDs
• Management of eCTD lifecycle during and after submission
• Assess eCTD readiness, consulting and training

Quality Assurance 

• GCP & GMP SOP development and review
• Support implementation of SOPs
• Web-based and on-site training
• Mock inspections and audits

Promotional Strategy and Review 

• Designing clinical trials for special promotional claims
• Critical review of promotional launch strategy
• Ongoing review of promotional strategy and literature
• FDA DDMAC liaison activities 

Pharmacovigilance 

• Conduct pre-marketing risk assessments
• Implement risk minimization procedures
• Perform pharmacovigilance and epidemiological assessments
• REMS development and FDA negotiation

Clinical Research 

• Identify and select qualified investigators and study sites
• Project management support
• Clinical study start-up & close-out
• Monitoring of ongoing studies and sites
• Preparation of local and FDA regulatory documentation

Pharmaceutical and Medical Device Procurement 

• Supply of bulk drug, intermediates and raw materials
• Supply of pharmaceutical packaging materials
• Contract manufacture of clinical investigational supplies
• Contract manufacture of medical device components
• Complete solutions for setting up pharmaceutical plants