As a pharmaceutical company, finding the best contractor to handle the production of your product is a critical step. Choosing from one of the top contract pharmaceutical companies will result in a seamless product development, manufacturing, and packaging process. Choosing from an inexperienced or poorly managed company will result in the opposite experience.
With all the time and cost involved in getting approval for new medications entering the market, choosing from contract pharmaceutical companies based on price alone should never be considered. There is too much at stake, and costly delays and errors on the part of the contracted company can result in a competitor’s product getting to market first, reducing your chance of taking the largest part of the market share.
When considering a contract manufacturer, take the time to focus in on these factors. Then, once you have weeded out companies without the capacity, experience, and transparency in their process, it is time to compare costs.
Capability and Production Capacity
These are two slightly different, but related considerations. Capability means that the company you are considering as the experienced staff and the understanding of the process, regulations, validation methods and other factors that will be required for your job.
Capacity is the actual production ability of the company. Will they be able to scale up production if your market share expands? Are they able to complete your project given the existing customer load? Do they respond to your questions and requests for information promptly or are you left waiting for someone to return a call?
Compliance Record
It is often surprising to find out how many contract pharmaceutical companies have a past history, sometimes a recent history, with compliance issues. It is essential to complete due diligence with the FDA to ensure any companies you are considering have a clean slate when it comes to compliance failures.
The top companies are very transparent and will provide recent inspection reports as well as their standards and protocols to ensure full compliance to all standards throughout the facility.
