The development of a new medicine is a complex task and requires many iteration and decisions before a commercial launch. Some biotech and pharmaceutical companies in Latin America choose to outsource most or all of their medicine manufacturing efforts throughout the development phase with a contract manufacturing organization.
However, choosing the right contract manufacturer in Latin America is crucial in pharma manufacturing to ensure product success as well as your pharma company’s performance.
Enlisting the right pharmaceutical contract manufacturing organization is a critical decision that puts your brand’s reputation, supply chain, and patient safety in someone’s hands. For the best pharma product manufacturing relationship, here’s how to choose the right contract manufacturer.
Know What You Need From Them
The first step of choosing the right contract manufacturer in Latin America is to know precisely what you need. There are various CMO relationships you can have based on your business needs. For example, a tactical contractor is ideal for a single project or to become a helping hand in in-house productions.
Working with a contract manufacturer in South Africa can allow you to establish an ongoing and long-term relationship without giving too much control over decision-making. Otherwise, a strategic partnership with a CMO is a long-term relationship between you and the CMO to accomplish defined business goals by maximizing the effectiveness of each participant’s resources.
Many pharmaceutical companies in Latin America and South Africa are looking for a reliable CMO to support their projects-right from the development phase to clinical trials and commercial pharmaceutical API manufactures and production and drug manufacturing, product formulation, and packaging. For these pharma companies, a strategic partnership is the best option.
Create a List of Top Contract Manufacturing Organization
Create a shortlist of top pharmaceutical Contract manufacturers you’re interested in working with, and analyze every CMO on the same characteristics and needs to single out the right partner eventually. Finding contract manufacture in Latin America is as simple as searching local CMOs or asking industry colleagues for references.
Ensure Quality and Compliance Standards
For safety and your reputation, the pharmaceutical contract manufacturing service you choose should be reliable. Make sure that they have a strong standing with regulatory agencies like the FDA and WHO. Check if they have had in past relationships for gaps in quality and consistent drug manufacturing.
Do not forget to request a report of their recent inspections, audits, and investigations. You won’t want to hire Third-Party contract manufacture in Latin America, Middle East, and South Africa that doesn’t host regular inspections and audits—or one that may be hiding their poor results. This could result in your product shipments’ drug delay or cancelation due to your contract manufacturer’s poor compliance.
Consider Their Experience and Expertise
Considering the capabilities of potential CMOs is an essential step in the process. You’ll need to determine if your pharmaceutical drug manufacturer has the capability and expertise required to manufacture your product. To do so, think about their expertise and experience. You do not want to become the trial run for your CMO, so find out about their previous experience.
Read research and reviews, ask for referrals, or consider hiring a consultant to help evaluate CMO’s profile. You must request that your CMO share key performance indicators they have in place and their success in meeting client expectations.
When evaluating their expertise, you’ll have to make sure it is in the realm of what you’re looking for. This shows they can finish similar needs. However, don’t just assume they have the right capabilities depending upon what they’ve done previously. You’ll still have to be upfront about exactly what you are looking for to make sure they meet your individual expectations and requirements.
Room for Growth
Like choosing a CMO with broad pharma manufacturing services, the pharmaceutical contract manufacturer in Latin America should provide room for growth. An ideal CMO can grow with your pharma product’s success. As such, this contract manufacture should have the proper equipment, staffing, and flexibility to handle your production cycle as it grows.
The issue of confidentiality can be crucial when it comes to formulation development. A confidentiality agreement is a must-have document, and it should be draft in a way to benefit both parties. Evaluate how the potential CMO ensures confidentiality. The pharmaceutical contract manufacturer should have a system in place that limits the usage of client names or initials, locks data in a secure area, and sends separate client passwords for electronic access to documents.
There are many things to consider when choosing the right CMO in Latin America for your pharmaceutical product. Carefully assessing your needs, capabilities, reputation, the CMO’s abilities, and previous expertise is the ideal way to build a successful partnership.