Feb 14, 2022
Nov 02, 2022
FDA Issues Draft Guidance on the OTC Monograph User Fee Program
Nov 01, 2022
Best OTC Products for Digestive Problems
Oct 28, 2022
Pharmacy Benefits Frequently Asked Questions
Oct 20, 2022
FDA proposes select updates to Breakthrough Devices Program guidance, including clarification of how the program applies to products that address health disparities
Nov 08, 2021
Oct 30, 2022
A New Method for Environmental Risk Assessment of Pollutants Based on Multi-Dimensional Risk Factors
Oct 27, 2021
Ukraine developing umbrella brand for export of products from micro, small, and medium enterprises
Aug 12, 2022
CSL brings Seqirus, Vifor under parent umbrella brand in identity revamp
Mar 10, 2022
Maxim healthcare group retires umbrella brand, divisions form two separate companies
May 31, 2022
Jul 19, 2022
Japan to Publish Revised Risk Assessment Methods for Priority Assessment Chemical Substances (PACs) under the Chemical Substance Control Law (CSCL)
Jun 24, 2022
Japan ISHA Identifies 4 Substances that have a High Risk to Health
Jun 05, 2022
Japan releases a new version of the online tool for GHS classification and labelling
Nov 07, 2022
Proposal to regulate 26 new chemicals and chemical groups
These markets are ones where the team has gained hands-on experience; yet, the team remains eager to explore and support new markets & opportunities.
If you are a non-EU manufacturer looking to market your products in the European Union, appointing an EU Authorised Representative (EU AR) is a legal requirement under various EU regulations, including EU GPSR (General Product Safety Regulation), MDR (Medical Device Regulation), IVDR (In Vitro Diagnostic Regulation), and CE Marking Directives.
KNOW MOREExpanding into international markets requires thorough compliance with diverse regulatory frameworks. Our International Regulatory Affairs services provide expert guidance to ensure your products meet the necessary requirements for global market entry, covering regions such as the European Union, United States, Asia-Pacific, Latin America, and the Middle East.
KNOW MOREBringing innovative products to market requires rigorous scientific and technical expertise to ensure compliance with regulatory standards. Our Scientific and Technical Guidance services provide specialized support in product development, regulatory submissions, and compliance with international safety and quality standards.
KNOW MOREIn an increasingly regulated and environmentally conscious world, businesses must ensure that their products are safe, sustainable, and compliant with global regulations. Our Product Stewardship and Innovation Support services provide expert guidance to help companies develop responsible products while meeting regulatory, environmental, and consumer expectations.
KNOW MOREIn today’s complex regulatory landscape, businesses must comply with various national and international regulations to ensure market access and consumer safety. Our Regulatory Compliance services provide expert guidance to help companies navigate the intricate web of compliance requirements, reducing risks and facilitating smooth product approvals.
KNOW MOREEnvironmental regulations are becoming more stringent worldwide, requiring businesses to adopt sustainable practices and demonstrate compliance with environmental laws. Our Environmental Compliance services provide expert guidance to help companies manage their environmental responsibilities, reduce risks, and achieve sustainability goals.
KNOW MOREbusinesses in the Cosmetic and Consumer Goods industries face increasing pressure to align their supply chains with global compliance standards. Addressing challenges such as contaminants, allergens, sustainability claims, and evolving regulations requires robust documentation and a comprehensive approach to traceability.
At the heart of compliance lies the ability to document, validate, and monitor raw materials (RMs) effectively. A well-documented and traceable supply chain ensures that products meet both regulatory expectations and consumer trust standards.
KNOW MOREMaintaining compliance with safety regulations is essential for protecting employees, consumers, and the environment. Our Safety and Compliance Internal Audit services help businesses identify risks, implement corrective actions, and meet national and international safety standards.
KNOW MOREEnsuring that products are safe and compliant with regulatory standards is crucial for consumer protection, market approval, and brand reputation. Our Product Hazard, Risk Assessment, and Mitigation services help businesses identify, evaluate, and manage potential risks associated with their products, ensuring they meet industry and regulatory requirements.
KNOW MOREIn an increasingly complex regulatory environment, businesses need robust scientific advocacy and regulatory strategies to ensure product acceptance, compliance, and market success. Our Scientific Advocacy and Regulatory Strategy services provide expert guidance to help companies navigate regulatory frameworks, engage with authorities, and build strong scientific positioning for their products.
KNOW MOREBringing a product to market requires a deep understanding of regulatory requirements and a strategic approach to approvals. Our Regulatory Approvals and Market Authorization services ensure that your products meet all necessary compliance standards, enabling seamless market entry and long-term success.
KNOW MORECompanies manufacturing or supplying hazardous substances in the EU must comply with Poison Centre Notification (PCN) and SCIP Notification requirements. Our expert services ensure that your products meet these obligations, enabling smooth market access and regulatory compliance.
KNOW MOREIn today’s global market, ensuring that product labels comply with diverse regulatory requirements across different regions is essential. Our Label Harmonization and E-Label services provide companies with expert solutions to streamline compliance, enhance consumer communication, and leverage digital labeling technologies.
KNOW MOREAt UpThink, we provide comprehensive regulatory support across multiple industries, ensuring compliance with global and regional standards. We help businesses navigate complex regulatory landscapes, manage product safety and quality assurance, and achieve market authorization efficiently. Whether it’s ensuring GMP compliance for pharmaceuticals, sustainability compliance in packaging, or food safety regulations in processing, our tailored solutions enable businesses to meet legal requirements while maintaining innovation and growth. By partnering with us, companies can confidently expand into new markets, adhere to evolving industry regulations, and uphold the highest standards of product integrity and consumer safety.