Regulatory compliance
Biocair is a Good Distribution Practice (GDP) compliant logistics specialist, so our experts across the global network ensure that every stage of each shipment is managed with care, knowledge and precision.
GDP compliance
GDP requirements must be met to ensure legal and safe shipping for the biotechnology, pharmaceutical and clinical trial sectors.
As global laws differ, Biocair provides time-saving assistance with customs tariff codes, classification of dangerous goods, labelling and other requirements.
As an Authorised Economic Operator (AEO) we work closely with major regulators, including the International Air Transport Association (IATA), Medicines Healthcare Products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA), to meet all regulatory and compliance requirements.
In-house Quality & Compliance Team
Our extensive knowledge of global shipping regulations, coupled with long-standing relationships with regulatory agencies, ensures that our internal QCT are well versed in transporting your materials to their destination on-time and in perfect condition.
Quality Management System
Biocair has been ISO certified since 2010 when the company was awarded ISO 9001:2008, and successfully transitioned to ISO 9001:2015 when the standard was revised.
GDP / GMP training
Our experts deliver a comprehensive and documented training program, including (where medicinal product shall be transported) appropriate GDP/GMP training and requirements for periodic retraining for all staff performing GDP/GMP activities.
Standard Operating Procedures (SOPs)
We will collaborate with you to create any SOPs you feel necessary, such as packing materials with strict temperature requirements or advising on storage needs.
Experts in the quality process
Our Quality and Compliance Team have over 100 years of cumulative experience. Within the team there is a Responsible Person who, along with their Deputy, has been trained extensively to the Cogent "Gold Standard".
Biocair's BSI certifications have established a control function that makes it easy to implement automated processes. The smooth and simple running of work processes confirms that they are acting in accordance with the standards.
British Standards Institution (BSI)
Classification of materials
Biocair classifies all materials to guarantee safe and compliant transportation:
- Hazards - for all domestic and international movements
- Government regulatory requirements
- Trade compliance – advising on valuation and customs coding to ensure clearances are smooth and auditable
Our priority is to avoid delays, endangerment to the materials in transit and disruption to your schedules. Biocair’s comprehensive classification process means products are always supplied with the correct declarations, licenses, permits, labelling and customs coding.
Tailored documentation
Biocair handles all labelling and paperwork, tailoring documentation to precisely meet the requirements of each shipment. We can complete compliant pro-forma invoices, air waybill/consignment notes and paperwork to accompany dangerous goods.
We also ensure compliance in transit, handling all labelling for your shipment on your behalf.
If we are unable to legally supply documentation, we can advise on proper completion or even supply you with templates, saving your team time and effort.
Contact our team today for support and advice on regulatory compliance.
FAQs
What is meant by ‘Regulatory Compliance’?
Biocair deals with regulations that govern the transport, import, and export of materials associated with the pharmaceutical, biotechnology, and medical research communities. When we refer to Regulatory Compliance, we mean that we work to and abide by those regulations, as well as industry, client, and our own internal standards.
What are the difficulties of ensuring Regulatory Compliance?
The sheer volume of regulation! There are local, national and international regulations; regulations that govern the transport of material; regulations that govern the export of material; regulations that govern the import of material, and all of these regulations are subject to constant change.
What are the consequences of non-compliance?
This depends upon which regulations have been breached. The consequences can range from delaying a consignment, which is particularly significant for temperature-sensitive items, to destruction of samples, large fines, and prosecution. It is therefore imperative that you are sure which regulations need to be observed with any consignment.
How can Biocair support with Regulatory Compliance?
We offer regulatory advice as part of our standard shipping service. Specific regulatory advice can also be provided as a separate service.
What licenses are required for shipments?
As with any aspect of regulatory compliance, the license requirements will depend upon the following criteria:
- Nature of the material
- Country of origin
- Destination
- Final use
Each of these aspects will affect which regulatory agencies are concerned with the consignment, and consequently what licenses and/or documents will be required. Biocair offers specific regulatory advice dependent upon these details.
Do I need to consider licenses if my shipment is being exported to an EU country?
Many EU countries have their own import requirements which sit alongside EU regulations. Some materials will always require licenses, regardless of wherever they are sent. Please contact your local Biocair office to check.
Get in touch with our experts
Wherever you are located in the world, our team of experts are on hand to support your supply chain.
