As a leading generic drug research company, Alfa Chemistry is committed to providing high-quality generic drug conformance evaluation services to global pharmaceutical companies, covering the full life process of pharmaceutical equivalence and bioequivalence.
The goal of our company is to help generic pharmaceutical enterprises evaluate the consistency of quality and efficacy between their products and RLD through our professional technical team and advanced experimental equipment. Our comprehensive conformance assessment services, ranging from policy consultation, project evaluation to final application to market, ensure that our customers' products meet regulatory requirements.
Alfa Chemistry's Services
Application for Consistency Evaluation
We provide a personalized conformance evaluation application service for different generic formulations to meet the needs of different clients and ensure the final approval of their products.
Pharmacovigilance Services
Our company provides generic drug manufacturers with integrated, flexible, and cost-effective pharmacovigilance services to assist in fulfilling regulatory pharmacovigilance responsibilities as required by regulations.
Generics Intelligence Services
Our company provides comprehensive generic drug intelligence services, including market size, patent protection, technical barriers, regulatory oversight, the competitive landscape, etc.
Regulatory Assistance
Our company provides a series of regulatory support services for generic drug enterprises, including registration consultation, document writing, application submission, supplementary applications, etc.
Our Advantages
- We have a good record of regulatory compliance
- Advanced instrument systems to ensure the efficiency of project completion
- We have helped customers successfully apply for multiple generic drugs to the FDA and NMPA
- Complete quality assurance system to ensure data accuracy, authenticity, traceability, and integrity
- Efficient work flow and standardized operation standards
- We have established a good cooperative relationship with clinical research institutions to efficiently integrate resources
- We provide customized consistency evaluation and declaration strategies for customers, manage project progress and risk
Work with us to advance the consistency evaluation of generic drugs. We believe that through our professional services, we can speed up the product development and marketing process, and ultimately achieve win-win results.
