Discover answers to common questions regarding accreditations and certifications designed for the life science and other regulated industries to protect the safety, security, and viability of materials.
What is an ISO accreditation?
International Organization for Standardization, or ISO from the Greek word isos meaning “equal,” is a non-governmental organization made up of global experts to create standards ensuring consistency and quality worldwide. These include quality management standards to improve efficiency and reduce product failures, health and safety standards to prevent workplace accidents, IT security standards to protect sensitive information, and more.
Our ISO accreditations are qualified through third-party organizations, DQS and A2LA. Both are overseen by the American National Standards Institute, which is a private, non-profit organization that administers and coordinates the US voluntary standards and conformity assessment system. In order to set high standards of excellence, competence, and compliance, DQS and A2LA are committed to impartiality through objective and fact-based certification decisions free from undue influence.
What are the benefits of achieving ISO 9001 certification?
ISO 9001 is the international standard for Quality Management Systems (QMS), which controls how work is performed, documented, reviewed, and corrected. By ensuring every process is controlled, employees are thoroughly trained, and investigations are done into any and all deviations, operations comply with life science regulations.
Currently accredited through DQS, SciSafe is compliant with ISO 9001 at all international facilities, including New Jersey, Massachusetts, and the Netherlands. Since achieving ISO 9001 certification, SciSafe has been inspected 9 times and received no non-conformance violations.
What is biobanking?
Biobanks are a type of biorepository which stores biological materials, typically human, for use in research. Through A2LA, SciSafe has been certified for ISO 20387 at our NJ facilities beginning in 2020, which is the international standard for biobanking that controls how biological samples are handled to ensure traceability, chain of custody, sample integrity, and data reliability across the full lifecycle to safeguard clinical and research materials.
Over the past 6+ years, SciSafe has had four ISO 20387 inspections, and there have been no non-conformance violations throughout that time.
Who needs to be FDA registered?
FDA registration is required for domestic and foreign establishments that manufacture, repack, or re-label drug products, biologic products (including vaccines), and animal drug products, establishments that manufacture human cells, tissues and cellular and tissue-based products (HCT/Ps), as well as blood establishments that collect, manufacture, prepare, and store under controlled conditions for further distribution or process blood and blood products. For more types of establishments that need to register facilities and products, visit the official FDA Registration and Listing page.
Since 2011, SciSafe has been FDA registered and inspected. Across seven FDA inspections, no 483 findings have been found, meaning that inspectors have not observed any conditions that constitute violations of related acts following the conclusion of each inspection. The inspections include five for CBER and two for CDER. CBER, or the Center for Biologics Evaluation and Research, regulates biological products for human use under applicable federal laws to protect and advance public health through biological products that are safe, effective, and available to those who need them. All of SciSafe’s US facilities are CBER registered. CDER, or the Center for Drug Evaluation and Research, regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs, along with sunscreens, antiperspirants, and fluoride toothpaste. Similar to CBER, the goal of these regulations is to make sure safe and effective drugs are available to improve the health of people in the US. SciSafe has had a CDER registration since 2018 for our NJ facilities.
What is a wholesale drug distributor?
To ensure risk mitigation, transparency and traceability, and the trust of patients, the FDA and local Departments of Health require stringent quality control throughout the pharmaceutical supply chain. Regulations vary by state, but in New Jersey, a wholesale distributor of drugs includes strict rules regarding:
- Organizations involved in wholesale distribution, such as manufacturers, repackagers, warehouses, and more
- Responsibilities for wholesale distributors include providing adequate storage areas (suitable size, cleanliness, temperature controls, and security), detailed recordkeeping, and due diligence
SciSafe was granted wholesale drug distribution licensure from the NJ Department of Health for NJ facilities in 2025, though additional licenses are required for other states, which can be applied for on an as-needed basis to support our life science partners through commercialization.
What is a biorepository?
Biorepositories are specialized facilities that can provide specimen collection, processing and storage, quality control, quality assurance, data management, distribution, and more for biological samples for scientific research. The College of American Pathologists’ Biorepository Accreditation Program, or CAP-BAP, was the first accreditation program to improve the quality and consistency of biorepositories. CAP-BAP demonstrates a commitment to excellence as it covers not only the physical locations, but all associated biorepository activities performed by personnel as well. This voluntary accreditation results in high-quality human specimens and genetic materials to better support research, drug discovery, and precision medicine.
With all our US facilities accredited, SciSafe is one of only four CAP-BAP accredited biorepository institutions in New Jersey, and one of only two in Massachusetts, where the only other accredited institution is a hospital. Our biorepositories have since undergone four rigorous inspections and have received no citations for deficiencies, ensuring compliance is maintained and we provide the highest level of quality in biospecimen storage and other processes.
What are the EU guidelines for Good Distribution Practices?
Through the European Medicines Agency, or EMA, compliance with GDP ensures that medicines are properly stored, contamination is avoided, medicines in the supply chain are authorized in accordance with EU legislation, and more. Those engaged in the wholesale distribution of medicinal products within the European Economic Area, or EEA, are required to register with the relevant competent authorities while complying with the principles of GDP for active substances.
SciSafe’s API Registration Certificate (17759 API) was acquired through the Netherlands Health and Youth Care Inspectorate Ministry of Healthcare, Welfare, and Sport, or IGJ. This certification covers active substances for medicinal products for human use (2015/C 95/01).
How does PMDA compare to the FDA?
In Japan, the Pharmaceutical and Medical Devices Agency, or PMDA, is a regulatory agency that works with the Ministry of Health, Labour and Welfare, or MHLW, to protect public health by ensuring the safety, efficacy, and quality. The PMDA mandates the registration and accreditation of overseas companies making or storing drugs, quasi-drugs, or medical devices. (Note: quasi-drugs are products that fall in between cosmetics and pharmaceuticals, and have the purpose of hygiene or preventing symptoms, such as sunscreen.)
Unlike other regulatory agencies, like the FDA, each organization must have their own Foreign Manufacturer Accreditation through the PMDA to distribute to Japan, rather than SciSafe holding a lone registration to distribute on a life science partner’s behalf. On a client-specific basis, SciSafe is able to provide the storage of drug products for distribution to Japan.
What are IATA Dangerous Goods?
The International Air Transport Association, or IATA, is an airline trade association with global standards for safety, security, efficiency, and sustainability. IATA’s Dangerous Goods Regulations are a regulatory framework for shipping hazardous materials via air transport.
Dangerous Goods Regulators help SciSafe in the classification, marking, packing, labelling, and documenting of dangerous shipments and hazardous materials in compliance with air transport regulations. Shipments that are not IATA-compliant can be refused and detained, causing delays to shipments that may lead to temperature excursions, causing significant supply chain issues.
Who needs to register with FMCSA?
The Federal Motor Carrier Safety Administration, or FMCSA, is a federal safety and compliance administration program governing commercial vehicles and drivers in the US. Its primary goal as part of the US Department of Transportation is to reduce crashes, injuries, and fatalities involving large trucks and buses through activities like developing the standards to test and license commercial motor vehicle drivers, as well as improving safety performance and removing high-risk carriers. Companies that operate commercial vehicles, whether transporting passengers or transporting cargo in interstate commerce, must register with the FMCSA and have a USDOT number.
Beyond FMCSA, commercial intrastate hazardous material carriers who haul types and quantities requiring a safety permit must also register for a USDOT number. Compliance with FMCSA allows SciSafe to operate its own fleet of vehicles for biological and pharmaceutical transport and logistics in order to ensure direct control over drivers, routes, vehicles, and temperature integrity.
What is the difference between FMCSA and PHMSA?
Though both FMCSA and PHMSA are part of the US DOT, the FMCSA covers commercial vehicle and driver safety, while the Pipeline and Hazardous Materials Safety Administration, or PHMSA, is responsible for ensuring the safe transportation of energy and other hazardous materials. The PHMSA can grant Special Permits that allow for the safe transportation or handling of hazardous materials in ways not typically permitted.
In SciSafe’s case, PHMSA granted a special permit to allow the legal transportation of infectious biological materials in powered, temperature-controlled equipment rather than in passive packaging. This transportation permit authorizes SciSafe to utilize our own vehicles rather than shipping through third-party couriers, ensuring stricter control and traceability from our end.
What is the main purpose of accreditations?
Compliance with accreditations is the adherence and fulfillment of the standards produced and maintained by governmental regulatory agencies or independent, non-governmental associations in order to enhance product and service quality while helping organizations improve efficiency, minimize risks, and gain a competitive edge. Plus, in the biological and pharmaceutical industries, leading medical research institutes to start up biotechs to global pharmaceutical companies are all accountable to regulators, so accreditations and certifications show our dedication to strict procedures to properly safeguard materials.
SciSafe believes in providing customer-first solutions for biopharmaceutical storage and logistics from discovery through commercialization, which is why we continuously improve our accreditations to meet the specific and unique needs of the biopharma industry. Want to know more about our current accreditations, certifications in progress, or how we can apply for accreditations and certifications based on your unique needs? Contact us!