About
SciSafe

Who We Are

Founded in 2010, SciSafe has expanded from its original inception and now operates internationally to provide biopharmaceutical storage, sample management, and cold chain logistics solutions to our global network of partners that consists of major pharmaceutical companies, leading research institutes, and more. 

From the world’s largest global pharmaceutical companies to leading research institutes to biotech start-ups, our clients have specific and oftentimes unique needs. That’s why SciSafe has developed over 86 Standard Operating Procedures (SOPs), a robust Quality Management System (QMS), and Corrective And Preventative Action (CAPA) system modeled after the FDA required system (21 CFR parts 210 and 211) that govern all functions within our technologically advanced facilities.

To provide customer-first solutions for a wide range of components, active ingredients, and end products, we continuously improve and increase our certifications and accreditations, including: 

• FDA CDER (US facilities) and CBER (NJ facilities) registered since 2011
  • 7 FDA inspections with no 483 findings
• EU GDP Registration: 17759 API (NL facility) 
  • 2 EU GDP inspections with no non-compliance findings
• ISO 9001 (US and NL facilities) and ISO 20387 (NJ facilities) certified since 2020
  • 9 ISO 9001 and 4 ISO 20387 inspections with no non-conformance violations
• CAP-BAP accredited for all US facilities since 2023
  • 4 CAP-BAP inspections with no citations
• FDA-registered Wholesale Distributor (NJ facilities) licensed since 2025
  • Registration Number: 7202781
• TAPA AMERICAS FSR 2023 Level B Certified Site (East Brunswick, NJ facility) since 2026
• Foundation for the Accreditation of Cellular Therapy (FACT) Compliant
• ICH Q7 and ICH Q9
• GDP (Good Distribution Practices) such as:
  • 21 CFR part 600
  • 21 CFR part 1271
  • EudraLex Volume 4
  • Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)
  • cGMP temperature-controlled storage

What We Do

From the beginning, our expert staff identify your cold chain storage and logistics needs and assist with strategic planning for sample transport. SciSafe ensures that all transfers have complete chain of custody transparency and documentation.

All of our storage facilities integrate cold chain management and cGMP-controlled temperature storage to deliver a reliable and comprehensive solution for managing your critical, invaluable materials. We provide outsourced storage across various temperatures, including Controlled Room Temperature, refrigerated, frozen, and custom conditions. 

When we receive pharmaceutical, biological, and consumer good materials, we adhere to and strictly enforce the following regulations: 

• Premier inventory control and distribution processes.
• Easy identification of biological material on the exterior of the samples.
• Component testing of all samples that are distributed to customers.
• Written instructions on how the sample is made.
• All pharmaceutical and biological samples are placed within containers that provide complete closure to help eliminate the possibility of contamination.