If you manufacture or import e-liquids or e-cigarettes (ENDS) into the European market, you are required to notify the competent authority in the member state (country) in which you wish to sell your product, 6-months prior to placing your product on the market, under the requirements of the Tobacco Products Directive (TPD).
Fundamental to the notification process is the generation of data on the safety of your product when used under reasonable and foreseeable conditions to ensure that products do not pose a risk to consumer health.
Our state-of-the-art ENDS lab offers a full suite of TPD product testing for both e-liquids and e-cigarettes including;
- Nicotine dose consistency
- Carbonyls/Aldehydes in aerosol
- Metals analysis in e-liquids and in aerosol
For more information on our TPD testing and notification services, click here.
Whether you are selling or intending to sell CBD containing products in the United States or within the European market, our laboratory offers a full spectrum of tests to meet your needs including:
- CBD Assay
- CBD:THC ratio
- Maximum THC content
- CBD related substances
- Metals analysis
- Microbiological evaluation
- Preservative efficacy testing
Our in-house stability facility provides comprehensive testing for CBD product shelf-life determination including both real-time (long-term) in accordance with ICH Q1 guidelines. We use UKAS calibrated measuring equipment to ensure storage conditions remain within the specified limits required to shelf-life studies.
All test methods used are fully validated in accordance with the principles and intent of ICH Q2 and WHO method validation guidance and have undergone appropriate determination of specificity, accuracy and precision to ensure integrity of data.
Our laboratory operates to Good Laboratory practices and follows ISO17025 processes and procedures.
Electrical product compliance is diverse and broad in reach with emerging requirements across medical devices and ENDS (e-cigarettes). Working with our partner labs, Inter Compliance offers a single point test house for electrical product compliance. Our experts can advice on the appropriate testing for your product and manage all areas of testing and compliance including:
IEC 62133 – portable lithium cell testing
Electromagnetic Compatibility (EMC)
Restriction of certain hazardous chemicals and substances (RoHS)
We offer a full range or proposed FDA tests for ENDS including:
- Draw resistance
- Puff count
- Coil resistance (built)
- Battery voltage (charged/uncharged)
- Maximum surface temperature during use
- Safety cut-off
Stability studies are performed on products to ensure that products are safe and of appropriate quality through its intended shelf-life. Such studies usually involve the testing of samples of product over the course of time whilst storing samples under controlled temperature and humidity.
Inter Compliance has expertise in the design and conduct of such studies to evaluate product shelf life from protocol design through to reporting of data in a manner appropriate for regulatory submissions.
Our inhouse storage chambers are compliant with ICH conditions and we offer testing at:
- 25℃/60% RH (Long-term storage)
- 30℃/65% RH (Long-term storage/intermediate)
- 45℃/70% RH (Accelerated storage)
Stability studies conducted for:
- Medical Devices
- Electronic Nicotine Delivery Systems (ENDS)
- Novel Foods
- CBD containing products
Pharmaceuticals and medical devices are required to undergo testing to demonstrate product safety. For pharmaceuticals, this is known as pharmaceutical development. Testing related to safety should be conducted to Good Laboratory Practice.
Our laboratory complies with the requirements of Good Laboratory Practices for the generation of data intended to support product safety in regulatory review. Whether characterization of product particulars or stability testing our comprehensive testing offers a complete service for clients. Where services are required beyond our labs scope, we work with a network of partner labs to offer our clients a single point solution. Our services include:
- Product shelf-life/stability studies
- Medical device verification and validation
- Product characterisation
- Microbial method suitability
- Cytotoxicity testing/biocompatibility
- Metals analysis
Contact us for more information on pharmaceutical & medical device testing
PMTA product testing requirements can be complex despite guidance available to the industry. Inter Regulatory offers a single point for the management of testing to support PMTAs, from Harmful and Potentially Harmful Constituents (HPHC) testing to stability studies and biocompatibility. Given the broad reach in testing requirements for PMTA, we have partnered with a UKAS/A2LA accredited laboratory and US FDA audited test house to ensure the highest quality of data is generated. Our testing services include:
- Full suite HPHC analysis
- Microbiological testing
- Cytotoxicity testing/ biocompatibility
- Shelf-life determination
- Device characterization and shelf-life determination
Contact us for more information on PMTA testing
Combining regulatory and scientific expertise, we offer our clients pragmatic solutions for all product types.