About Dicentra
Dicentra: Your Trusted Partner for Regulatory Compliance and Safety
Dicentra is a leading CRO (Contract Research Organization) and regulatory consulting firm that specializes in providing comprehensive solutions to businesses operating in the food, dietary supplement, natural health product, cosmetic, medical device, and pharmaceutical industries. With over 20 years of experience in the industry, Dicentra has established itself as a trusted partner for companies looking to navigate complex regulatory frameworks and ensure compliance with safety standards.
At Dicentra, we understand that navigating the regulatory landscape can be challenging for businesses of all sizes. Whether you are a startup looking to bring your first product to market or an established company seeking to expand your product line or enter new markets, our team of experts is here to help you every step of the way. We offer a wide range of services designed to address matters of safety, quality and compliance for products.
Our Services
Regulatory Consulting: Our team of experienced consultants provides expert guidance on regulatory requirements across various jurisdictions. We help clients navigate complex regulations related to labeling requirements, claims substantiation, ingredient safety assessments and more.
Product Development: Our experts work closely with clients throughout the entire product development process โ from concept ideation through commercialization โ ensuring that products meet all necessary regulatory requirements while also meeting consumer needs.
Clinical Trials: We provide end-to-end clinical trial management services including protocol development & review; site selection & management; data collection & analysis; report writing & submission.
Quality Assurance: Our Quality Assurance team helps clients establish robust quality systems that meet international standards such as ISO 9001/13485/17025/22716/GMP/GLP/GCP/GDP etc., ensuring consistent quality across all aspects of their operations.
Safety Assessments: Our toxicology experts conduct thorough safety assessments on ingredients used in food supplements/natural health products/cosmetics/pharmaceuticals/medical devices etc., helping clients ensure that their products are safe for use by consumers.
Regulatory Compliance: We help clients ensure that their products meet all necessary regulatory requirements across various jurisdictions, including FDA, Health Canada, EU, TGA and more. Our team of experts stays up-to-date with the latest regulatory changes to ensure that our clients remain compliant at all times.
Why Choose Dicentra?
At Dicentra, we pride ourselves on providing personalized service to each of our clients. We understand that every business is unique and requires tailored solutions to meet its specific needs. Our team of experts works closely with each client to develop customized solutions that address their unique challenges and goals.
We also understand the importance of speed-to-market in today's fast-paced business environment. That's why we work efficiently and effectively to deliver results quickly without compromising quality or safety.
Finally, we believe in transparency and open communication with our clients. We keep our clients informed throughout the entire process so they can make informed decisions about their products and operations.
Conclusion
In conclusion, if you are looking for a trusted partner who can help you navigate complex regulatory frameworks while ensuring compliance with safety standards for your products โ look no further than Dicentra. With over 20 years of experience in the industry and a team of experts who stay up-to-date with the latest regulations across various jurisdictions โ we are well-equipped to help you achieve your goals while mitigating risks associated with non-compliance. Contact us today to learn more about how we can help your business succeed!