An ISO9001 Certified Supplier of Pre-Clinical Contract Research Service and Analytical Service
Protheragen-ING Lab understands the critical importance of regulatory compliance in today's complex and fast-moving business environment. We can also help our clients ensure compliance and global market access for their products by providing comprehensive regulatory support and global market access services to companies in a wide range of industries. Our commitment to excellence, technical expertise, international network, and comprehensive services make us the ideal partner for companies seeking reliable regulatory support in today's global marketplace.
Comprehensive compliance solutions
Our team of experienced experts and consultants has the technical expertise and in-depth knowledge of international regulations to help you confidently navigate complex regulatory environments. We will work closely with you to provide tailored solutions to effectively address your regulatory compliance challenges.
We leverage our technical expertise, international network, and various resources to provide a one-stop shop for compliance services, including product compliance consulting and technical services, product registration, security consulting, digital solutions, and investment and financing.
Our one-stop global market access services cover a diverse range of industries, including active pharmaceutical ingredients (APIs) and excipients, pharmaceuticals, medical devices, general chemicals, and pesticide registration.
Our regulatory support services in this area include comprehensive analysis, documentation, and compliance strategies to help you navigate the complex regulatory environment. We assist you in meeting the necessary guidelines, such as Drug Master Files (DMF), Import Regulation, and other relevant regulations.
We have in-depth knowledge of global pharmaceutical regulations and can guide you through the entire product lifecycle. From pre-market approval to post-market surveillance, we provide comprehensive regulatory support to help you achieve compliance and bring your medicines to market efficiently and safely.
Our medical device regulatory support services cover all aspects, including classification, quality management systems, risk assessment, labeling requirements,, and post-market surveillance. We assist you in developing and implementing a robust regulatory strategy to meet stringent regulatory requirements, such as FDA's 510(k) clearance, CE marking, and other international standards.
Our regulatory support services in this area include hazard assessment, chemical registration, safety data sheet (SDS) preparation, labeling compliance, and regulatory advocacy. We help you navigate complex regulatory frameworks such as REACH, GHS and other regional or national regulations to ensure that your products meet the necessary safety and compliance standards.
With our extensive knowledge of pesticide regulations, we can guide you through the registration process efficiently. We assist with data compilation, risk assessment, efficacy evaluation, labeling compliance, and preparation of submissions for pesticide registration, ensuring that your product meets the necessary regulatory standards.
Other Industries
We understand the unique regulatory challenges faced by different industries and customize our services to your specific needs to ensure compliance with relevant regulations and standards.
Typical steps in the product registration process
- Determine the specific regulations and requirements applicable to your product in your target market.
- Gather and prepare the necessary documentation to support your product registration, including technical data, manufacturing information, safety and efficacy studies, and any other information required by the regulatory agency.
- Submit an application to the regulatory agency, which typically includes the required forms, supporting documentation, and fees.
- Once the application is submitted, the regulatory agency will review the documents.
- During the review process, the regulatory agency may request clarification or additional information.
- If the application meets all requirements and the product is deemed to comply with the regulations, the regulatory agency will approve.
- After the product is registered, post-approval obligations may be required, such as periodic reporting, safety monitoring, labeling updates, and compliance with post-market surveillance requirements.
Contact us today to discuss your specific regulatory support needs and learn how we can help you achieve compliance and global market success.