Totell.bio
Regulatory Affairs & Technical Writing
Our regulatory affairs team ensures seamless navigation through the complex landscape of clinical development regulations. We provide strategic guidance and comprehensive support to help you achieve compliance and expedite your product's path to market.
Our expert medical writers craft clear, precise, and comprehensive documentation that meets regulatory standards. From clinical study reports to regulatory submissions, our professionals deliver high-quality content that enhances your project's success.
Submissions & Applications
(domestic and international)
Pre-IND
Pre-NDA
Investigational New Drug (IND)
New Drug Application (NDA)
Abbriviated New Drug Application (ANDA)
Biologics License Applications (BLA)
Specialized Designations
Orphan Drug Designation (ODD)
Fast Track
Accelerated Approval
Priority Review Designation
Breakthrough Therapy Designation
Document Changes & Maintenance
Government agency/health authority representation and mediation
FDA Attorneys
Former FDA Reviewers
Submissions & Applications
(domestic and international)
Pre-IND
Pre-NDA
Investigational New Drug (IND)
New Drug Application (NDA)
Abbriviated New Drug Application (ANDA)
Biologics License Applications (BLA)
Specialized Designations
Orphan Drug Designation (ODD)
Fast Track
Accelerated Approval
Priority Review Designation
Breakthrough Therapy Designation
Document Changes & Maintenance
Government agency/health authority representation and mediation
FDA Attorneys
Former FDA Reviewers
Medical & Technical Writing
Investigational Brochure (IB)
Informed Consent
Protocols
Literature reviews
Conference posters
Investor presentations
Formatting
Hyperlinks
Modules
eCTD Publishing
San Diego, CA info@Totellinc.com
