Let us assist you in meeting your regulatory compliance needs and product development objectives.

•  Submission strategy and planning 
• Document–level publishing (document formatting & conversion, PDF document processing including bookmarks & hyperlinks, datasets)
• Submission-level publishing (eCTD dossier compilation, quality view, technical validation, inter-document hyperlinking)
• Identifying regional requirements (US and Canada)
• Submission lifecycle management
• Act as liaison for FDA submission inquiries
• Health Canada Regulatory Enrollment Process 

•   Strategy Planning & Management 

                       - Early development approval pathway planning

                       - Regulatory agency interactions planning & support

                       - Regulatory intelligence research

                       - Review of documentations

                       - Develop and manage submission timelines

                       - Gap Analysis

• FDA Meeting Request Package  

                       - Write/review meeting request

                       - Prepare/review briefing document

                       - Type A, B and C meeting requests

                       - Manage FDA meeting request process

• Pre-IND, IND, & NDA Package (including preparation, submission, and maintenance) 
• 505(b)(1) and 505(b)(2) pathways 
• US agent and Canada regulatory representative
•  Lifecycle management and maintenance  

•   QMS Development & Support 

                      - Develop & implement quality management system

                      - Write/update/review of SOPs for GxP activities

                      - Gap analysis on SOPs and QA system

                      - QA strategy and planning

• GxP Audits  

                      - Regulatory inspection readiness and response

                      - Investigational site audits and pre-inspections

                      - Inspection/audit response & remediation support

                      - Consultation and follow-up of CAPAs

                      - Supplier/Vendor audits

• CAPA management 
• PAI assessment/training readiness  

• CMC strategic expert input & regulatory advice
• Documentation & due diligence review
• Gap analysis
• Method/process validation
• Regulatory authorities interactions (Pre-IND, IND, EOP2, Pre-NDA, NDA, and post marketing)
• Project status review for regulatory submission readiness
• Technical/regulatory writing & editing in eCTD format
• Biosimilar BLA strategy
• Inclusive regulatory strategy for investigational & commercial products
• Project & lifecycle management