At Unibest Industrial, we are committed to supporting our clients through the final and most critical phase of drug development—securing regulatory approval for commercialization. Our comprehensive NDA (New Drug Application) and BLA (Biologics License Application) services are designed to ensure that your drug or biologic product meets the highest standards of safety, efficacy, and quality, ultimately leading to successful market entry.
Regulatory Strategy and Submission
Customized Regulatory Plans
Our team of experts develops tailored strategies to align your NDA/BLA submission with the requirements of global regulatory authorities such as NMPA, FDA, and EMA.
Comprehensive Documentation
We assist in preparing and organizing all necessary documentation, including clinical trial reports, manufacturing data, quality control measures, and pharmacovigilance plans.
Submission Management
We manage the entire submission process, ensuring timely and accurate filing of your NDA/BLA application.
Regulatory Strategy and Submission
Customized Regulatory Plans
Our team of experts develops tailored strategies to align your NDA/BLA submission with the requirements of global regulatory authorities such as NMPA, FDA, and EMA.
Comprehensive Documentation
We assist in preparing and organizing all necessary documentation, including clinical trial reports, manufacturing data, quality control measures, and pharmacovigilance plans.
Submission Management
We manage the entire submission process, ensuring timely and accurate filing of your NDA/BLA application.
GMP Compliance
Our QA team ensures that all manufacturing processes and facilities comply with Good Manufacturing Practice (GMP) standards, both domestically and internationally.
Facility Audits
We conduct thorough audits of manufacturing sites to identify and address any potential issues before submission.
Regulatory Inspections
We provide support during regulatory inspections, ensuring that your facilities and processes meet all required standards.
Quality Assurance and Compliance
Quality Assurance and Compliance
GMP Compliance
Our QA team ensures that all manufacturing processes and facilities comply with Good Manufacturing Practice (GMP) standards, both domestically and internationally.
Facility Audits
We conduct thorough audits of manufacturing sites to identify and address any potential issues before submission.
Regulatory Inspections
We provide support during regulatory inspections, ensuring that your facilities and processes meet all required standards.
Data Compilation and Analysis
Clinical Data Integration
We compile and analyze clinical trial data to demonstrate the safety and efficacy of your product, ensuring that it meets regulatory expectations.
Manufacturing Data Review
Our experts review and validate manufacturing data to ensure consistency, quality, and compliance with regulatory guidelines.
Statistical Analysis
We provide robust statistical analysis to support the strength of your application.
Data Compilation and Analysis
Clinical Data Integration
We compile and analyze clinical trial data to demonstrate the safety and efficacy of your product, ensuring that it meets regulatory expectations.
Manufacturing Data Review
Our experts review and validate manufacturing data to ensure consistency, quality, and compliance with regulatory guidelines.
Statistical Analysis
We provide robust statistical analysis to support the strength of your application.
Regulatory Correspondence
We assist in addressing any questions or requests from regulatory authorities, ensuring timely and comprehensive responses.
Approval Strategy
We develop a strategic plan to address potential post-approval requirements, such as Phase IV studies or additional clinical trials.
Market Entry Support
Once approved, we provide support for market entry, including label design, packaging, and distribution planning.
Post-Submission Support
Post-Submission Support
Regulatory Correspondence
We assist in addressing any questions or requests from regulatory authorities, ensuring timely and comprehensive responses.
Approval Strategy
We develop a strategic plan to address potential post-approval requirements, such as Phase IV studies or additional clinical trials.
Market Entry Support
Once approved, we provide support for market entry, including label design, packaging, and distribution planning.