CMC & QA

CMC Documentation

Capabilities

Extensive experience in:

• Preparation of all types of regulatory CMC documents for worldwide submission from early development to submission (in CTD format) and post approval
  
• Preparation of European and US DMFs for drug substances and site master files for aseptic facilities (US type V DMFs)
  
• Preparation of briefing packages for HAs meetings/written consultation on specific CMC subjects
  
• Implementation of regulatory strategies that decrease development time and optimize resource availability from early development to submission and for Life Cycle Management
  

Strengths

• regulatory specification development;
  
• stability study design
  
• development and use of electronic document management systems
  
• development and use of customized templates

Quality Assurance

Capabilities

Extensive experience in:

• All GMP aspects concerning the manufacturing and control of drug substances and drug products
• Developing comprehensive quality systems in compliance with current US and EU requirements
• Preparation to HAs inspections (Pre-approval and GMP inspections)
• Auditing contractors and vendors
• Developing facilities, utilities, equipment validation programs
• Developing process validation programs, including aseptic processes
• Assessment of bulk and packaged goods for approval and release
• GMP review of batch records, including all manufacturing tickets for drug substances and drug products

Strengths

• Successful history of US and EU (Italian) authorities inspections (GMP and GLP)
• Quality systems implementation to fulfill European and US GMP requirements, such as SOPs management, training, change control etc.
• Ensure full compliance with European Clinical Trial Directive (2001/20 EU)
• Ensure GMP/GCP interactions are fulfilled as requested by the Annex 13
• Support the activities for validation of computerized system to ensure compliance with EU and US requirements (CFR 21 - part 11 compliance -electronic signature and records)