For Product Development and Manufacturing
- ComplyWell Solutions can perform batch compliance review almost in real time due to its proximity to the pharmaceutical manufacturing hub in India. With the increased scrutiny of the relationship between the CMO and the marketing authorization holder by the regulatory authorities, it will increase your confidence in the product you use for clinical studies or for distribution in the market. It will also help alleviate the chances of an investigation, product hold or recall post-distribution.
- ComplyWell Solutions can assess the batch compliance off-site or on-site by reviewing the identified records including material, manufacturing, QC and QA records and alert you within hours of its manufacture. This will help to reduce the distribution time and your resource requirement leading to better and efficient use of the internal resources.
ComplyWell Solutions can also support in the periodic review of your contract manufacturers and their records.