Developing any new pharmaceutical product is a time consuming and exacting process to ensure patient safety and full adherence to all production requirements and regulations. Most pharmaceutical companies will use contract drug manufacturing companies throughout the process, providing specialized, expert services as opposed to manufacturing the medication in-house.
Choosing from different contract manufacturers can be challenging, particularly if this is a first experience for the pharmaceutical company. Not understanding all the possible services for contract drug manufacturing companies is one potential problem, so taking the time to learn what is offered by top companies will be an important first step.
Expertise and Experience
There are startup contract drug manufacturers just as there are start up pharmaceutical companies. While both can be well-run and have the required level of expertise, the experience with the approval process through the FDA and the legal requirements for bringing a new drug to the market can be an issue.
Ideally, look for a contract drug manufacturer with years in the industry and the experience in producing a wide range of pharmaceutical products. This ensures knowledge of the requirements and the ability to assist the in-house team.
Capacity and Cost
Not all contract drug manufacturing companies have the capacity to take on another customer and provide the priority, personalized attention required. It will be critical to talk to the contract manufacturer and verify that all phases of development as well as the clinical trial process.
The best companies have the capacity and capability to work with the supply chain to transition seamlessly from clinical trials into full-scale production with approval. This includes assisting your in-house team with the appropriate type of medication form, analytics, and testing as well as packaging requirements.
The cost will also be a factor with any contract manufacturer. Ensure that all quotes received include the same services and also provide details on timelines for the process to make an informed choice in a contract manufacturer.
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