● Labels are designed according to the required language (English, Spanish, Russian, etc.)
● Diversified packaging options (canned, bagged, cardboard drum)
Formula concentration is not adjustable.
Can assist in completing the revision of the Chinese Pharmacopoeia standards (such as updating the implementation standards from the 2005 edition of the Chinese Pharmacopoeia Part II to the 2010 edition Part II), and handle compliance changes in the instructions and labels.
Having the ability to act as a drug registration agent, we can provide DMF document preparation services, covering the writing of review materials for active pharmaceutical ingredients, excipients, and packaging materials.
When it comes to drug advertising, it is necessary to strictly comply with national regulations and avoid using illegal content such as efficacy comparisons.
● Client Briefing: Understand the client's specific API requirements, including its structure, purity, and desired scale.
● Feasibility Study: Assess the technical and economic viability of developing and manufacturing the API.
● Quotation & Contract: Provide a cost estimate and finalize the agreement with the client.
● Route Scouting: Identify and select the most efficient chemical synthesis routes.
● Process Optimization: Refine reaction conditions, crystallization, separation, and purification steps to maximize yield and purity.
● Analytical Method Development: Develop and validate methods for testing the API's quality.
● Lab-Scale Synthesis: Produce small batches to demonstrate process viability and generate samples for testing.
● Pilot Plant Production: Manufacture larger quantities to validate the process at a semi-commercial scale.
● Process Validation: Ensure the process consistently produces the API according to predefined quality standards.
● Raw Material Sourcing: Procure necessary starting materials and reagents.
● Production: Execute the scaled-up, validated process under stringent Good Manufacturing Practices (GMP) conditions.
● In-Process Controls: Monitor the manufacturing process at various stages to ensure quality.
● Finished API Testing: Perform comprehensive tests on the final API batch to confirm it meets all specifications.
● Stability Studies: Conduct studies to determine the API's shelf life and appropriate storage conditions.
● Documentation: Prepare all necessary documentation, including certificates of analysis and batch records.
● Logistics: Arrange for the safe and timely delivery of the API to the client.