Services

Our services include regulatory compliance, regulatory submissions, training and more. Please contact us for your inquiries.

Regulatory Compliance

• Establishing quality management system (GLP, GMP, GCP, QSR)
• Providing internal audit (GLP, GCP, GMP, QSR, HIPAA)
• Equipment/analytical instrument qualification (DQ, IQ, OQ, PQ)
• Computer system validation (21 CFR Part 11 compliance)
• Process validation
• Software design and development for 21 CFR Part 11 compliance
• Contractor and supplier audits
• Responding to FDA 483 and FDA Warning Letter
• Risk analysis
• CAPA handling

Regulatory Submissions

• U.S.: IND, NDA, ANDA, IDE, 510(k), PMA
• China: CCC application and medical device registration
• EU: Medical Device CE Mark
• Electronic Submissions:
  • Option 1: Provide complete eSubmission service
  • Option 2: Provide eSubmission IT support and training
  • Option 3: Convert paper documents to searchable PDF files
  • Option 4: Create XML documents including XML style sheets

Trainings

• GLP, GCP, GMP
• Design Controls, QSR, ISO 13485
• 21 CFR Part 11
• How to handle external audits
• Risk management: regulatory requirements and technical solutions
• Document and change controls for regulatory compliance
• Electronic submission process and technical solutions

Translation Services

• English to Chinese translation for regulatory submissions in China
• Chinese to English translation for regulatory submissions in the US

Start-up Services

• Assist VC evaluation on regulatory affairs planning and cost estimation
• Provide complete regulatory affairs outsourcing solutions to start-up companies

 

• GLP
• CCP
• GMP
• QSR
• 21 CFR Part 11
• Medical Device Submissions in the US
• Medical Device Compliance in the US
• Design Control