Generic drugs are of great significance in improving drug quality, lowering drug prices, enhancing drug accessibility, and promoting the high-quality development of the pharmaceutical industry. Alfa Chemistry is committed to providing high-quality regulatory support for generic drug companies. We offer solutions to problems in generic drug filing from the perspective of customer requirements, offering a series of registration services covering the entire drug life cycle, including registration consulting, document writing, filing submission, and supplemental application.
Our Services
Regulatory Consulting
Major countries and regions around the world have introduced a number of policies to improve the quality and safety of generic drugs and the efficiency of review and approval. We monitor regulatory updates issued by drug regulatory agencies worldwide and provide consulting services to clients on regulations related to registration, manufacturing, marketing and quality control of generic drugs.
Regulatory Impact Analysis
We analyze the impact of regulatory and policy changes on the generics market for our customers, including the impact of new policies on generic R&D, manufacturing costs, and market access.
Compliance Guidance and Feasibility Analysis
We provide customized compliance guidance services to help clients ensure that their products and operations meet the latest regulatory requirements. We analyze the feasibility of drug registration for the client's generic project based on the regulatory requirements in the client's region.
Specialized Training
We provide specialized generic regulatory training services to help clients enhance their internal teams' skills and knowledge.
Application Document Preparation
We prepare a full set of documents according to the registration regulations and filing requirements. Specifically, the following services are included:
- Providing an outline catalog of filing information and sorting out the list of detailed information
- Development of a filing strategy and timing of various points according to the client's project
- Conducting a gap analysis of registration data and suggesting modifications to the client
- Format review, translation, preparation and submission of the documents
- Following up on the progress of the official review, assisting with answering questions and submitting additional information
Our Advantages
- We have set up a comprehensive regulatory support team, which has conducted in-depth research on drug regulations in the U.S., EU, Japan, and China, and we provide all-around, high-level compliance services for all types of clients.
- We pay real-time attention to the dynamics of various drug regulatory agencies and understand the latest laws, regulations and guidelines.
- We have rich experience in consulting projects and standardized service process management to ensure high-quality service processes and a good customer experience.
- We establish long-term and friendly communication channels with regulators and industry experts to significantly improve service quality and efficiency.
- We have a professional writing team, which has helped many projects to complete registration filings.
- We have a team of business elites in English, Japanese, German, Chinese and other languages to efficiently serve our international clients.
We specialize in providing comprehensive, professional and efficient generic regulatory services to help our clients stay competitive in the generic market and ensure product quality and market compliance. Our services are designed to enable you to strategically develop generic products, rationally seize growth opportunities, and enter new markets quickly and in a compliant manner, ultimately maximizing benefits.
