1. Why should I choose Ceutical Labs?
Ceutical Labs formed to meet a need in the industry that did not exist before. Many contract manufacturing facilities provide some regulatory assistance, but none of them provide the full package that Ceutical provides. We take a concept and develop the concept into a marketed product. The owner only need participate as desired in the project and reap the rewards.
2. How large a project can Ceutical handle?
Ceutical is prepared to deliver on your project no matter the size. Ceutical has the resources and experience at its disposal to meet your needs, from small assistance to the global project and delivery. Ceutical has assisted small “Mom and Pop” companies to Fortune 100 companies.
3. I manufacture nutraceuticals. How can Ceutical Labs assist me?
Great question! The FDA has begun a movement to implement GMP’s into the nutraceutical market. The FDA is positioned to ensure the American public of good products that meet the label claims. With the example of ephedra, the FDA reacted to an existing issue and removed ephedra from the market. The FDA seized product in the marketplace, thus costing companies millions of dollars.
What Ceutical Labs proposes is the advancement of a solid quality system to meet the global quality standards, ensure profitability of the company, and provide the manufacturing site with a Ceutical Seal of Approval. When a consumer sees the Ceutical Seal, the consumer is assured of quality. When the company is prepared for global distribution, the documentation for the quality system will become key to product entry. The initiation of GMP’s and the Ceutical Seal of Approval will increase sales, ensure profitability, and ensure a global presence.
4. I don’t like regulations and how can I get around them?
Interesting question, but Congress enacted laws that force manufacturers to produce quality products that do not harm the general public. Congress also gave permission to the FDA to enforce these rules and regulations. Because they are laws, we must obey or pay the consequences.
5. Ceutical Labs has a large variety of services, are there specialties within Ceutical Labs?
Ceutical Labs personnel have a vast and varied background to meet the current and future needs of the industries that it participates. These industries include Pharmaceuticals (including OTC), Medical Devices, Nutraceuticals, Pet Products, Recruiting, and Cosmetics. We are here to help solve problems and avoid non-compliance issues. Our personnel have backgrounds in all the above industries with specialization in product development, quality assurance, quality control, regulatory submissions, clinicals, sales, marketing, information technology, web design, business development, and so much more. We have never faced a problem that did not have a suitable solution.
6. Compliance costs are extremely high. Why are these costs so high?