Biopharmaceutical & Pharmaceutical Chemical Solutions

Yes, our North Carolina production site is ISO 13485-certified and 21 CFR 820-compliant, ensuring full GMP compliance and consistent quality across global supply chains.

Absolutely. We provide formulation and filling of sterile and non-sterile products—including reagents, cell culture media, and USP WFI Quality Water—in scalable volumes up to 1000 L .

Yes, with decades of expertise in flexible packaging and containment systems, we deliver tailored solutions that integrate seamlessly into your workflow and meet your process requirements.

Yes, we support everything from small batches to commercial-scale production. Our services include blind/white labeling, engineering support, and on-site lab capabilities to protect your proprietary IP.

Yes, we specialize in formulating our customer’s chemical solutions to meet their designed specifications. Our collaborative approach ensures smooth transitions from development to commercialization—accelerating your time to market

Yes, our release testing is validated to meet USP and other relevant standards, ensuring regulatory compliance and quality assurance.

Yes, we offer sterile filtered products that meet rigorous testing standards. Full validation is available upon request to support specific regulatory requirements.

Yes, we provide WFI Quality Water suitable for a wide range of pharmaceutical applications, with scalable options based on customer needs.

We support pharmaceutical, biopharmaceutical, and medical device markets—including organ preservation, wound care, safety solutions, and cell culture.

Yes, we have extensive experience supporting regulatory filings such as 510(k) submissions, stability studies, and packaging validation (e.g., leachable and extractables), backed by robust documentation.