CDMO
Solutions
Struggling with manufacturing delays, regulatory bottlenecks, or quality control issues? We deliver what matters most: products that meet specifications, on time, within budget. With 20+ years of experience and one of the industry’s fastest turnaround times, we solve the problems that keep development teams awake at night. As a cGMP-compliant contract manufacturer with FDA and EPA licenses and over two decades of experience, we provide reliable and cost-effective solutions, tailored to your specific needs and timelines. We specialize in developing private label products and product line extensions, utilizing our expertise in custom formulation and product improvement to help your business compete on quality, selection, and price.
Our team of regulatory specialists, with in-depth knowledge of global regulations, including FDA, EMA, and ICH guidelines, ensure perfect compliance across your clinical supply chain. From initial manufacturing to worldwide distribution, we prioritize the highest quality and safety standards, allowing you to concentrate on bringing vital innovations to patients.
Our Services
Development
We possess the versatility and in-depth knowledge to formulate specialty niche products across a wide spectrum, including anti-aging, acne, skincare, spa treatments, haircare, veterinary solutions, hand sanitizers, and nail products. Our dedicated R&D department excels at creating custom formulas, often starting from samples of creams, lotions, gels, and various consistencies in between. Let our experience and flexible approach drive your business forward.
Testing and
Improvement
We perform thorough raw material testing, develop analytical methods, conduct stability tests, and ensure regulatory compliance. We are skilled in customizing formulations to improve efficacy and expand market reach. Our deep expertise in biotechnological sciences and product development ensure your products achieve a strong position in the market.
Packaging
and Labeling
We offer comprehensive packaging and labeling services, executed by our dedicated team of professionals with expertise in handling complex regulatory guidelines. Our flexible and customizable solutions cover both primary and secondary packaging, precisely engineered to meet the specific requirements of your clinical trial and commercial protocols while ensuring full regulatory compliance.
Manufacturing
Our versatile facilities are equipped to handle a wide range of filling requirements, from small volumes of 1/3 ounce to large-scale runs up to 55 gallons. Our three concurrent manufacturing lines enable a single-shift production capacity of 437 gallons (1,654 Liters) and can be scaled to process up to 3,000 liters per day as needed. While we specialize in small to medium production runs (1,000 to 25,000 units), our flexible infrastructure allows us to accommodate larger batch sizes and filling projects as needed. This adaptability is a key factor in our ability to offer one of the fastest turnaround times in the industry
Supply Chain
Management
We employ robust supply chain management practices to ensure the uninterrupted flow of products. Our comprehensive inventory systems, coupled with meticulously maintained temperature-controlled storage and efficient logistics, guarantee timely delivery and complete traceability. These critical elements are paramount to minimizing risks, preserving product integrity, and safeguarding efficacy.
Comparator
Sourcing
We understand the intricacies of sourcing suitable comparator products for your clinical trials. Our extensive network of qualified suppliers, coupled with our stringent quality control processes, guarantees the procurement of reliable and fully compliant comparator drugs, enabling you to conduct accurate and clinically meaningful comparative studies with confidence.
Worldwide
Distribution
We offer comprehensive global distribution capabilities, ensuring your products reach any destination worldwide in full compliance with local regulations and import/export protocols. Our strategic partnerships with leading logistics providers enable us to expertly navigate the complexities of international shipments, guaranteeing efficient and reliable delivery.
Delivery and
Post-Delivery
Our accelerated production timelines help you achieve rapid market entry with minimized lead times. We provide comprehensive regulatory support, assisting with submissions and liaising with regulatory agencies. Our technical team ensures consistent product performance and reliability. We also assist in product enhancement through formulation improvement and exploring new indications to extend product lifecycle.
Our Services
Development
We possess the versatility and in-depth knowledge to formulate specialty niche products across a wide spectrum, including anti-aging, acne, skincare, spa treatments, haircare, veterinary solutions, hand sanitizers, and nail products. Our dedicated R&D department excels at creating custom formulas, often starting from samples of creams, lotions, gels, and various consistencies in between. Let our experience and flexible approach drive your business forward.
Testing and Improvement
We perform thorough raw material testing, develop analytical methods, conduct stability tests, and ensure regulatory compliance. We are skilled in customizing formulations to improve efficacy and expand market reach. Our deep expertise in biotechnological sciences and product development ensure your products achieve a strong position in the market.
Manufacturing
Our versatile facilities are equipped to handle a wide range of filling requirements, from small volumes of 1/3 ounce to large-scale runs up to 55 gallons. Our three concurrent manufacturing lines enable a single-shift production capacity of 437 gallons (1,654 Liters) and can be scaled to process up to 3,000 liters per day as needed. While we specialize in small to medium production runs (1,000 to 25,000 units), our flexible infrastructure allows us to accommodate larger batch sizes and filling projects as needed. This adaptability is a key factor in our ability to offer one of the fastest turnaround times in the industry
Packaging and Labeling
We offer comprehensive packaging and labeling services, executed by our dedicated team of professionals with expertise in handling complex regulatory guidelines. Our flexible and customizable solutions cover both primary and secondary packaging, precisely engineered to meet the specific requirements of your clinical trial and commercial protocols while ensuring full regulatory compliance.
Supply Chain Management
We employ robust supply chain management practices to ensure the uninterrupted flow of products. Our comprehensive inventory systems, coupled with meticulously maintained temperature-controlled storage and efficient logistics, guarantee timely delivery and complete traceability. These critical elements are paramount to minimizing risks, preserving product integrity, and safeguarding efficacy.
Comparator Sourcing
We understand the intricacies of sourcing suitable comparator products for your clinical trials. Our extensive network of qualified suppliers, coupled with our stringent quality control processes, guarantees the procurement of reliable and fully compliant comparator drugs, enabling you to conduct accurate and clinically meaningful comparative studies with confidence.
Delivery and Post-Delivery
Our accelerated production timelines help you achieve rapid market entry with minimized lead times. We provide comprehensive regulatory support, assisting with submissions and liaising with regulatory agencies. Our technical team ensures consistent product performance and reliability. We also assist in product enhancement through formulation improvement and exploring new indications to extend product lifecycle.
Worldwide Distribution
We offer comprehensive global distribution capabilities, ensuring your products reach any destination worldwide in full compliance with local regulations and import/export protocols. Our strategic partnerships with leading logistics providers enable us to expertly navigate the complexities of international shipments, guaranteeing efficient and reliable delivery.
Challenges We Solve
Small batch manufacturing eliminating high MOQ requirements
Rapid formulation changes during development
Complex regulatory requirements across multiple markets
Supply chain disruptions and raw material sourcing