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What we cater
Science #1
Beauty and Personal Care Research and Development Solutions
We understand that your products need to meet high standards while achieving progress to market quickly and cost effectively.
Our broad cosmetic development support expertise supports your research and development, marketing, licensing and distribution of products through services which enable strict control and evaluation of safety, efficacy and acceptability including:
- Consumer Healthcare Trials
- Global Regulatory Compliance for Cosmetic Products
- Toxicological Risk Assessment
- Cosmetics Testing
- Cosmetics Prohibited or Restricted Ingredients Testing
- Cosmetics Allergen Screening Testing for 57 Potential Allergens by GC-MS/MS
Consumer Healthcare Trials
TM Biotech Labs is a leading supplier of consumer healthcare trials, which include tests for safety, efficacy and claim support. We offer access to a large, characterized, volunteer database and a diverse network of investigators including Dermatologists, GPs, Biochemists and Statisticians. Safety testing expertise includes patch testing, sensitization, in-use tolerance, and photo-safety. Our efficacy and claim support expertise covers skin care, hair and scalp care, SPF and water resistance and specialist in vitro testing for oral care products,
Toxicological Risk Assessment
Most of the international regulations (EU, USA, Japan, China, Russia...) cover all aspects of cosmetic safety, ranging from human health and safety assessments to Good Manufacturing Practice (GMP), packaging and labeling.
The EU regulations on the safety of cosmetics (Directive 76/768/EEC) apply to all cosmetic products manufactured within or imported into the EU. TM Biotech Labs services include:
- Design and interpretation of human studies
- Safety assessment of cosmetic products
- Advice on ingredient listing and labeling.
- Advice on the legal status of ingredients
- Management of regulatory affairs and product safety
- Assessment of consumer complaints
- Quality Management and GMP
Science #2
Beauty & Personal Care
TM Biotech Labs provides a comprehensive range of services for beauty and personal care products to ensure quality, safety, efficacy, and regulatory compliance.
Whether you are a global manufacturer, an international brand, a retailer, or an importer selling beauty and personal care products, product safety and quality are vital.
The beauty and personal care industry is driven by a constantly evolving regulatory landscape and the development of new technologies. Innovation is crucial to the successful development of new cosmetics products. However, with the use of new ingredients and materials, the industry is continually challenged to develop safe, effective, and compliant products that meet the requirements of both legislation and consumers.
Partnering with TM Biotech Labs helps brands and producers to speed up their international growth, optimize the quality and safety of their supply chain and reduce total costs. We have more than 30 years’ knowledge and experience of providing safety and cost-effective services across all aspects of the beauty and personal care industry. Our services range from research and development and clinical development support to new products and notification, manufacturing, and ongoing support.
For R&D services:
We provide analytical support for formulators, quality control, substrate/product interaction from our analytical laboratories. We also provide human trials for safety and efficacy, claim substantiation from our clinical study center in Paris, France, and toxicological assessment from our network of toxicologists in the UK, France and North America. We can also support the due diligence of materials used in primary packaging.
For production site:
We provide quality control testing and comprehensive GMP services to production sites to be ready for the implementation of the Cosmetic GMP and the EU Cosmetic Regulation. This includes gap analysis, training, consultancy, eLearning tools and self-evaluation. In addition, our scientific support services help with contamination investigations and product scale-up questions and challenges.
For the supply chain:
Our global network of GMP auditors can perform third party audits of the raw material and packaging suppliers with local experts. Inspection and testing of materials are performed on the spot before shipment to reduce risks and unnecessary costs.
TM Biotech Labs solutions include:
- Beauty and Personal Care Research and Development Solutions
- Cosmetic Safety Assessment and Toxicology Services
- Personal care product trials supporting claim substantiation, safety and efficacy.
- In Vitro Oral Care Product Laboratory Testing
- Analytical Cosmetic Testing
- Alternative Testing Methods such as in vitro, in silico and in chemical laboratory expertise
- Scientific and Regulatory Consulting
- Supply Chain Management and Audit Services
- ISO 22716 Certification
Science #3
Chemical testing
Basic and industrial chemical testing and regulatory services to help meet quality and regulatory standards and optimal efficiency across the supply chain.
Basic and industrial chemicals are produced in huge quantities and are critical ingredients for products used by both industry and the general consumer. They include chemical raw materials derived from oil (petrochemicals), basic inorganics and intermediates for chemical processes.
Understanding the manufacturing processes and the chemical composition of these basic chemicals is important in order to meet cost reduction targets and to comply with increasingly stringent environmental and safety regulations.
Hand Sanitizer Testing Services
Our scientists test and analyze basic and industrial chemicals which are used in a range of industries such as specialty chemicals, polymers, agrochemicals, pharmaceuticals, detergents, solvents, textiles, and many others. Tests include chemical composition and physical properties, conducted to international standards including ASTM and ISO, and in-house methods assist your quality control testing, trace analysis and contamination issues.
We also provide comprehensive consulting support for developing and implementing worldwide regulatory compliance strategies for new and existing products. Our services relate to new product introductions, data development, as well as validation of compliance of existing products with local and global regulations, delivered with Total Quality Assurance.
TM Biotech Labs’s support for the manufacturing process includes safety services for chemical powders and scientific consultancy for implementation and monitoring of on-line and at-line measurements. We also know that assuring the longevity and safety of your materials and plant infrastructure are key priorities. At TM Biotech Labs, our corrosion and asset integrity experts can provide testing and consultancy in the areas of chemical treatments, corrosion control and production chemistry to promote safety and lower the risk of materials failure.
To help navigate the complex supply chains and distribution routes, our cargo inspection and supply chain auditing services can safeguard your products and minimize risk.
Wherever you are positioned in the supply chain, our network of laboratories, capabilities and Total Quality Assurance expertise is delivered consistently with precision, pace, and passion to support your research or manufacturing, ensuring your products and processes reach optimal quality and efficiency.
With the emergence of COVID-19, governments around the world have established quality guidelines to ensure that the ingredients used in the preparation and distribution of hand sanitizers and disinfectants meets applicable safety requirements.
TM Biotech Labs can help clients optimize raw materials selection and testing, as well as finished product testing, to ensure that safe, high-quality products reach global markets quickly.
Raw Materials Testing
Testing of the raw material components used in sanitizers and disinfectants helps manufacturers verify ingredients and screen for impurities to ensure the products are safe for use.
- Alcohol Testing (Ethanol Impurities): Ethanol impurities can be harmful or even toxic. TM Biotech Labs offers gas chromatography testing for ethanol purity, including ethanol content (up to 98.8%), methanol content, and other impurities. Testing is offered to standards such as United States Pharmacopeia (USP), Federal Chemical Codex (FCC) testing, and many more.
- Gas Chromatography (GC) Analysis: The major components of alcohol-based hand sanitizers include alcohols that are quite volatile like ethanol, methanol, n-propanol, and iso-propanol. Using GC, the volatile compounds of interest are primarily separated based on boiling point, and GC columns with polar selectivity provide additional intermolecular interaction (such as dipole interaction) to separate individual components based on polarity.
Finished Product Testing to Industry and Regulatory Standards
TM Biotech Labs tests sanitizers and disinfectants as finished products, including third-party verification of:
- % IPA in finished product
- % Ethanol in finished product
- Chemical characterization of packaging such as polymeric tubing, filters, etc.
Depending on where a product will be marketed, it is important to consider the applicable safety and quality standards for each region. TM Biotech Labs can verify compliance to a variety of global standards, including:
- EU: Biocidal Products Regulation No 528/2012
- EN: Antibacterial Tests EN1040 and EN1276
- US: OTC Topical Antimicrobial Drug Products (21 CFR)
- Canada: Health Canada – Antiseptic Skin Cleansers Monograph
- Australia: Therapeutic Goods (Excluded Goods—Hand Sanitizers) Determination 2020
- New Zealand: Cosmetic Product Group Standard 2017 (HSR002552), Guideline on Regulation of Therapeutic Products