Technology
Chemistry at work
Product
W&J PharmaChem invites you to navigate through our thousands of uniquely functionalized heterocycles, advanced intermediates and active pharmaceutical ingredients. The product list is still growing everyday. To name a few, these products include alcohols, amines, pyridines, nucleosides, quinines, polycyclics, chirals, etc. We ardently offer our chemistry capability to customers for specific compounds elected by them. From route design to chemistry execution, we are here to help you meet synthetic needs on time and on budget. The synthesis is carried out by well trained chemists in the state-of-art labs.
Chemical method development
What is unique about W&J PharmaChem is that our technology platform extends from research and exploratory chemistry to more defined, chemical process oriented validation chemistry. Using technology and knowledge of chemistry, we provide you a great leverage to evolve your discovery phase compounds to clinical candidate. Complying with FDA and international directives on pharmaceutical manufacture, we instill quality and regulatory requirement early in the chemistry endeavor. Thus W&J PharmaChem will help design the experiments and address the issues regarding critical process parameters. By the definition and control of these parameters, issues such as product quality and limits of impurities can then be addressed. From small scale, multi-step synthesis to pilot trials of larger quantities, our process engineers will work for you to achieve the objectives. Of course, all scientific data, particularly of those from pharmaceutical chemistry method development and validation studies, will not be usable without proper documentation. Using our well developed and proven approach, we will generate crucial documents such as batch records and the validation reports often needed for regulatory purpose.
Quality control and assurance
To the less experienced, the quality assurance may mean either flatly plain or formidably complex. But we know exactly what it implies and where to apply it. Using risk based approach and design space concept, effective and economic QA systems have been generated and applied to monitoring manufacture process of APIs. Success has been achieved with the approval of system by customers and regulatory officials alike.
Dossier Preparation and Submission
If you are satisfied with our discovery and development chemistries, it is only logical to benefit further from our experiences in dossier preparation. Taking reference of ICH guidelines, we will incorporate the most relevant information into each section of certain document format. As mentioned above, some sections of the dossier must be developed early in the synthesis of API or advanced intermediates. A well compiled document should be such that will not be receiving heavy comments from regulatory agency in the deficiency letter. Again we will help our customer to communicate with FDA and to formulate strategy for getting supplementary information to be added in response letter.
US agent
Last but not least, we can serve as your agent in your product registration with FDA. Once the document is accepted, we will maintain communicated with FDA and assist you to perform annual requirement regarding the product registration.
Project management
As our customer, you will appreciate our “project update” feature in which you know where your project stands, from the project planning stage to final product shipment. You can also make comments once you log in as a user
About our database
The structure search feature of our database greatly facilitates the customer to review and compare compounds with common structural attributes. It also allows you to group and cluster our products in the way you like.