Generic drugs are generally defined as drugs that have the same therapeutic effect as RLD, and consistency evaluation refers to the need to meet both pharmaceutical equivalence and bioequivalence. Registration and application of generic drugs is a key area of concern for pharmaceutical companies, and its complexity and duration may vary greatly from project to project. The importance of entering the market as early as possible and occupying a leading strategic position is self-evident. Improving the level of filing documents and submitting complete documents is the key to the success of generic drug applications.
Our Services
Alfa Chemistry is committed to providing comprehensive and scientific generic drug development and application services for pharmaceutical enterprises. Our company undertakes all kinds of generic drug research and development and consistency evaluation services worldwide. Our services include RLD research, formulation process evaluation and redevelopment, analytical method development and validation, quality standard research, stability research, pilot/scale-up/process validation production, application document writing, assisting with on-site inspection, etc. We work closely with our clients to ensure a thorough understanding of their drug filing objectives in order to provide flexible solutions. We follow a rigorous scientific technology and quality system to ensure compliance with each project.
Scope of Our Services
- Provide agency services for overseas drug application
- Drug registration data analysis, risk assessment, and guide customers to supplement and improve
- Preparation, proofreading, review, confirmation and submission of applications and documents
- Follow up on the progress of regulatory agencies, actively communicate with reviewers and answer questions
- Submission of supplementary information during the review process
- If necessary, assist in accepting the supervision department's on-site inspection, answer the examiner's questions, and rectify the defects
- Change and maintenance of marketed drugs
- Application for re-registration of marketed drugs
- Drug application consultation
Service for Different Formulations
With extensive practical experience and efficient team cooperation, we provide personalized conformity assessment and declaration solutions for different formulations of drugs and customers.
- Oral solid preparations, including ordinary tablets, sustained-release tablets, enteric-coated tablets, capsules, granules, etc.;
- Oral liquid preparations, including oral solutions, suspensions, syrups, drops;
- Injections, including small injections, large volume injections, freeze-dried needles, dispensing needles, and concentrated solutions for injection.
- Generic transdermal patches
- Generic inhalation formulations
- Generic ophthalmic drugs
Why Choose Alfa Chemistry?
- We have set up an experienced professional and technical team, familiar with the requirements of generic drug consistency evaluation, and have the advantages of specialization and efficiency
- We have established a close cooperative relationship with many research institutions and clinical research institutions around the world, and carry out relevant research work according to customer needs
- Up to now, we have successfully assisted customers to complete a number of generic drug development and application projects, and accumulated rich experience in project management and other aspects
- We always maintain a good relationship with regulatory agencies, more convenient and timely communication with reviewers
Alfa Chemistry is a high value added partner focused on solving all of the challenges our clients face prior to market access to generic drugs. From feasibility studies to final approval, we have helped numerous clients bring drug candidates to market. Our scientific knowledge base, technical expertise and reputation for quality service allow us to build long-term partnerships with our clients and that is why we remain at the forefront of global generic research.
