Generic drugs play a crucial role in the current pharmaceutical market as they not only increase the accessibility of medicines but also reduce the financial burden on patients. Oral solid dosage forms are one of the most common drug forms, including tablets, capsules and granules. Consistency evaluation of generic oral solid dosage forms involves not only the chemical composition of drugs, but also bioequivalence, the formulation process, stability and many other aspects.
Our Services
As a leading generic conformity assessment service company, Alfa Chemistry is committed to helping our clients ensure that their products match the quality and efficacy of the RLD. At Alfa Chemistry, we understand the importance of assessing the consistency of oral solid dosage forms to ensure the safety, efficacy, and quality of medicines. We provide more professional and comprehensive oral solid generic drug consistency evaluation services, including but not limited to the following.
- Chemical Composition Analysis
Active ingredient: Our company ensures that the active ingredient of the generic drug is the same as the RLD through reverse analysis and reference review.
Excipients: Our company selects appropriate and cost-effective excipients for our clients' generic projects to ensure the stability and efficacy of the drug.
Pharmacokinetic study: Our company evaluates the bioequivalence of generic drugs to the RLD through parameters such as blood concentration and time profile.
Bioavailability assessment: Our company analyzes the rate and extent of absorption of generic drugs in the body to assess the bioavailability of the drugs.
- Pharmaceutical Process Evaluation
Particle size and distribution: We strictly control particle size and distribution to ensure consistency and stability.
Formulation Process: Our company evaluates and optimizes the formulation process to improve the quality and consistency of the drug product.
Accelerated Stability Testing: We evaluate pharmaceutical stability by simulating extreme conditions.
Long-term stability tests: We design rational long-term tests to assess the stability of drugs under actual storage conditions.
Quality standards: We establish strict quality control standards for pharmaceutical products in accordance with the latest version of international standards.
Quality control: We ensure that each generic drug batch meets established quality standards.
Quality management: We establish a comprehensive quality management system for our clients.
We collect and analyze all research data related to our clients' generic drug projects. We ensure the completeness, authenticity and accuracy of the data by establishing a strict data management system and taking all necessary measures. We prepare detailed manufacturing process documentation for regulatory review.
- Application Material Preparation
We help our clients prepare complete application materials, including study data, production process documents, quality control reports, etc.
We develop effective communication strategies to assist our clients in communicating well with regulatory authorities and responding to their feedback and requirements in a timely manner to ensure the smooth progress of the filing process.
Our Capacity
- Efficient integration of resources with experience of successful approval of multiple generic drug products
- In-depth research and compliance with national regulatory agencies, and timely adaptation to regulatory updates and changes
- A number of senior scientists, as well as a professional service team
- Standardized operating procedures and comprehensive and compliant report templates
- Advanced instruments and equipment
- Extensive and close partners, including clinical trial organizations
