By Scott Jenkins , COO, Biovation Labs03.01.18
Nutraceutical companies spend significant time and resources conducting research and development, crafting marketing plans, and aligning their plans with market realities. One such reality is that companies, large and small, have two options when it comes to manufacturing their products. They can come up with and justify the capital expenditures needed to secure the necessary facility, fill it with safe, efficient manufacturing equipment and systems, train a large staff to the nth degree of competency, build a stellar supply chain and shoulder the spectrum of risks that come hand-in-hand with this undertaking, or they can outsource the manufacturing and partner with a nutraceutical and supplement contract manufacturer.
Some of the world’s most successful companies rely on contract manufacturers because it enables them to focus on R&D and marketing without having to worry about the manufacturing risk. The challenge comes with knowing what to look for when choosing the right partner. The following are 11 items to look for in a contract manufacturer.
Industry Certified
In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good Manufacturing Practices (GMPs) are guidelines that provide a system of processes, procedures, and documentation to assure that the product in the bottle or box has the identity, strength, composition, quality, and purity that appear on its label. This aligns with FDA’s 21 CFR part 111, which pertains to dietary supplements. NSF International independently certifies manufacturers as meeting GMP requirements. According to NSF, the program is open not just to manufacturers of dietary supplements but also to “manufacturers of ingredients and raw materials, as well as distribution, warehousing and packaging companies, who want to demonstrate their commitment to public safety.” Another industry certification that helps establish credibility includes the Natural Products Association’s (NPA) GMP Certification. This is awarded to companies that meet a high level of compliance to the NPA GMP Standard as verified through comprehensive third-party inspections of facilities and GMP-related documentation.
Location, Location, Location
Contract manufacturers located in the U.S. have some inherent advantages. Primarily, such companies are beholden to higher levels of scrutiny than in other countries, which pushes the companies to maintain higher levels of manufacturing quality. Drilling down, contract manufacturers should be located near major, reliable transportation hubs. The most important consideration is proximity to an international airport. This will allow the company to have easy access to fulfill orders in the most timely and efficient manner possible.
Ensure Quality
Testing protocols are not a given. The best contract manufacturers conduct continual testing to ensure two things: first that the product is pure, and second, as accurate as possible (label claim). To prove this, the company should go beyond what’s required. Micro testing looks for any impurities or contaminants. Assay testing ensures all the ingredients in the formulation that should be there are in fact present. For instance, if the label claims 65% of an ingredient, then it actually contains 65% of that ingredient. Heavy metal testing looks for lead and other metals to ensure safety. The best partner will spend the time and money for the testing that takes quality beyond regulatory requirements.
Global Supply Chain
Contract manufacturers today should be more to their customers than simply capsule fillers. They are partners in every sense of the word. The best contract manufacturers should have a global network upon which to help you, their customers, source the best materials from anywhere in the world at a reasonable price to maintain margins. They should also have validated suppliers with proven track records of delivering safe products that are consistent in their purity and composition.
Capacity
Contract manufacturers work with a number of companies. The best partners will work directly with their customers to help them clearly understand their capabilities, capacities, and calendars. If they are organized in the right way, they will make it clear when and how they will manufacture their product. If you have a small order, contract manufacturers are ideal because they can fulfill the order for you and you don’t need to buy the equipment. Companies with larger orders can rely on the fact that contract manufacturing is what they do best; they can handle massive orders due to high capacity being built into their business model.
Experience
Experience is a relative term, but in this high-stakes industry, nothing can replace the been-there, done-that know-how that only comes slowly but surely over decades. While everyone needs to start somewhere, the best contract manufacturers have leadership teams and managers with not just one or two years but two, three, or even four decades of industry experience. This helps ensure success by recognizing problems early and knowing exactly how to overcome them.
Facility & Equipment
The best contract manufacturers are those that meet your needs. To do that, they will need to have the right equipment for this particular industry. This means they have the equipment to deliver encapsulation, packaging, blister packaging, powder fulfillment and so on. Also, with today’s ever-expanding spectrum of products, it is important to know whether they have in-house fulfillment capabilities, including label printing, technical review, and 3PL distribution, or if they need to partner with a separate fulfillment house to meet your needs.
Delivery Time
Delivery time couldn’t be more vital. The contract manufacturer should understand your business hangs on them delivering on time. A typical delivery time is six to eight weeks, but the best will work with you to push for closer to the four- to six-week timeframe.
Pricing
Contract manufacturers should be very open regarding price. When people want quotes, they often flip to the final page to see the price. However, if all you look at is price, then you’re probably going to get stung in some other way. If the quality isn’t sufficient, you are responsible. When you market a consumer health product, price is only a part of the equation. The question is: are they delivering a product that matches what you are selling? Some are willing to sell a sub-par product. The best partners know there is a better way to manufacture. Price and quality often go hand-in-hand.
Transparency
This is where the relationship becomes solid or falls apart. The best contact manufacturers will be open and transparent with you from the beginning to the end to establish and fortify a relationship of trust and accountability. The company’s understanding of consumer needs and desires for nutritional supplements enables them to proactively strategize, innovate, and provide solutions to you that can meet your goals and help you grow.
Regulatory Training
One of the best things about partnering with a contract manufacturer is the fact that you do not need to understand all the regulatory items. Keeping up with regulations is part and parcel to the partnership—they should have training regimens to keep everyone in the entire company continually sharp and aligned with the current regulations and best practices. The best contract manufacturer can walk you through the requirements using simple language that helps you feel confident they have the ball and will not drop it. This also helps you rest easier knowing that by receiving appropriate training, they are working to remove risk from every step of the process.
By working with a contract manufacturer, you gain significant competitive advantages by being able to focus your efforts on your core competencies and running your business. The best contract manufacturers are experts at what they do and can help you achieve success in formulating, developing, and distributing your products to the world.
About the Author: Scott Jenkins is COO of Biovation Labs, a contract manufacturing, formulation, private label and supplier company within the natural products industry. The company works within the life science space, manufacturing products for supplement and nutraceutical companies worldwide. In January 2018, the company moved into its new 104,000 square foot corporate headquarters in Salt Lake City, UT, which houses a state-of-the-art, high capacity manufacturing facility, serving the needs of both large and early-stage companies. Biovation Labs follows cGMP standards. For more information: www.biovationlabs.com.
Some of the world’s most successful companies rely on contract manufacturers because it enables them to focus on R&D and marketing without having to worry about the manufacturing risk. The challenge comes with knowing what to look for when choosing the right partner. The following are 11 items to look for in a contract manufacturer.
Industry Certified
In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good Manufacturing Practices (GMPs) are guidelines that provide a system of processes, procedures, and documentation to assure that the product in the bottle or box has the identity, strength, composition, quality, and purity that appear on its label. This aligns with FDA’s 21 CFR part 111, which pertains to dietary supplements. NSF International independently certifies manufacturers as meeting GMP requirements. According to NSF, the program is open not just to manufacturers of dietary supplements but also to “manufacturers of ingredients and raw materials, as well as distribution, warehousing and packaging companies, who want to demonstrate their commitment to public safety.” Another industry certification that helps establish credibility includes the Natural Products Association’s (NPA) GMP Certification. This is awarded to companies that meet a high level of compliance to the NPA GMP Standard as verified through comprehensive third-party inspections of facilities and GMP-related documentation.
Location, Location, Location
Contract manufacturers located in the U.S. have some inherent advantages. Primarily, such companies are beholden to higher levels of scrutiny than in other countries, which pushes the companies to maintain higher levels of manufacturing quality. Drilling down, contract manufacturers should be located near major, reliable transportation hubs. The most important consideration is proximity to an international airport. This will allow the company to have easy access to fulfill orders in the most timely and efficient manner possible.
Ensure Quality
Testing protocols are not a given. The best contract manufacturers conduct continual testing to ensure two things: first that the product is pure, and second, as accurate as possible (label claim). To prove this, the company should go beyond what’s required. Micro testing looks for any impurities or contaminants. Assay testing ensures all the ingredients in the formulation that should be there are in fact present. For instance, if the label claims 65% of an ingredient, then it actually contains 65% of that ingredient. Heavy metal testing looks for lead and other metals to ensure safety. The best partner will spend the time and money for the testing that takes quality beyond regulatory requirements.
Global Supply Chain
Contract manufacturers today should be more to their customers than simply capsule fillers. They are partners in every sense of the word. The best contract manufacturers should have a global network upon which to help you, their customers, source the best materials from anywhere in the world at a reasonable price to maintain margins. They should also have validated suppliers with proven track records of delivering safe products that are consistent in their purity and composition.
Capacity
Contract manufacturers work with a number of companies. The best partners will work directly with their customers to help them clearly understand their capabilities, capacities, and calendars. If they are organized in the right way, they will make it clear when and how they will manufacture their product. If you have a small order, contract manufacturers are ideal because they can fulfill the order for you and you don’t need to buy the equipment. Companies with larger orders can rely on the fact that contract manufacturing is what they do best; they can handle massive orders due to high capacity being built into their business model.
Experience
Experience is a relative term, but in this high-stakes industry, nothing can replace the been-there, done-that know-how that only comes slowly but surely over decades. While everyone needs to start somewhere, the best contract manufacturers have leadership teams and managers with not just one or two years but two, three, or even four decades of industry experience. This helps ensure success by recognizing problems early and knowing exactly how to overcome them.
Facility & Equipment
The best contract manufacturers are those that meet your needs. To do that, they will need to have the right equipment for this particular industry. This means they have the equipment to deliver encapsulation, packaging, blister packaging, powder fulfillment and so on. Also, with today’s ever-expanding spectrum of products, it is important to know whether they have in-house fulfillment capabilities, including label printing, technical review, and 3PL distribution, or if they need to partner with a separate fulfillment house to meet your needs.
Delivery Time
Delivery time couldn’t be more vital. The contract manufacturer should understand your business hangs on them delivering on time. A typical delivery time is six to eight weeks, but the best will work with you to push for closer to the four- to six-week timeframe.
Pricing
Contract manufacturers should be very open regarding price. When people want quotes, they often flip to the final page to see the price. However, if all you look at is price, then you’re probably going to get stung in some other way. If the quality isn’t sufficient, you are responsible. When you market a consumer health product, price is only a part of the equation. The question is: are they delivering a product that matches what you are selling? Some are willing to sell a sub-par product. The best partners know there is a better way to manufacture. Price and quality often go hand-in-hand.
Transparency
This is where the relationship becomes solid or falls apart. The best contact manufacturers will be open and transparent with you from the beginning to the end to establish and fortify a relationship of trust and accountability. The company’s understanding of consumer needs and desires for nutritional supplements enables them to proactively strategize, innovate, and provide solutions to you that can meet your goals and help you grow.
Regulatory Training
One of the best things about partnering with a contract manufacturer is the fact that you do not need to understand all the regulatory items. Keeping up with regulations is part and parcel to the partnership—they should have training regimens to keep everyone in the entire company continually sharp and aligned with the current regulations and best practices. The best contract manufacturer can walk you through the requirements using simple language that helps you feel confident they have the ball and will not drop it. This also helps you rest easier knowing that by receiving appropriate training, they are working to remove risk from every step of the process.
By working with a contract manufacturer, you gain significant competitive advantages by being able to focus your efforts on your core competencies and running your business. The best contract manufacturers are experts at what they do and can help you achieve success in formulating, developing, and distributing your products to the world.
About the Author: Scott Jenkins is COO of Biovation Labs, a contract manufacturing, formulation, private label and supplier company within the natural products industry. The company works within the life science space, manufacturing products for supplement and nutraceutical companies worldwide. In January 2018, the company moved into its new 104,000 square foot corporate headquarters in Salt Lake City, UT, which houses a state-of-the-art, high capacity manufacturing facility, serving the needs of both large and early-stage companies. Biovation Labs follows cGMP standards. For more information: www.biovationlabs.com.
