Global Consulting Services

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Business Services:

• Business Development lead generation
• Business Plans
• Establishing your own front end label to market
• Commercial outlook/forecasting
• Portfolio analysis and optimization
• Market analysis USA, Canada, EU
• Deal negotiations from term sheet to final MSA
• Merger & Acquisitions

We are pleased to provide our clients with Quality Assurance audits and Regulatory Audits.

• SOP Generation
• Quality Systems implementation
• QA Audits of manufacturing facilities and laboritories
• Regulatory Consulting services for filing pre-IND, IND, NDA, ANDA and BLA submissions
• Project Management
• FDA meetings

Over the past 30 years we have assisted Pharma and Bio-Pharma with their regulatory submission needs. We have supported over 155 INDs/NDA/BLA/ANDAs over the past 5 years. Our 200+ scientists cover all regulatory disciplines including nonclinical, clinical, CMC, compliance, publishing, and submissions.

Our Strengths:

• Utilization of AI in drug development to map diseases and drug candidates. Capabilities to Model and compare treatments and patient groups so you get a clear map of disease and drug mechanisms. Compare your treatments to competing treatments, and your drugs across patient populations.
• Real World Evidence submissions with large dataset to the FDA
• Pre-IND & IND submissions and regulatory process strategy-manage all interface with FDA
• Publishing and submissions for planning, tracking and communication with FDA and global health authorities. (BLA, ANDAs, DMF, NDA Preparation for FDA interactions. CDER interactions)
• Pre-clinical Regulatory review, CMC solutions, scientific & regulatory writing and NDA submissions in eCTD format