Our team of dedicated experts understands the nuances of both regional and international regulatory requirements. We provide end-to-end regulatory affairs services for a wide range of veterinary products, including pharmaceuticals, vaccines, feed additives, and biologicals. From initial product development to post-approval lifecycle management, we are committed to ensuring your products meet the stringent standards of global authorities.
Our Global Reach and Expertise
DDReg Pharma's expertise spans across key global markets, including the USA, EU, LATAM, GCC, and the Asia-Pacific region. We work closely with local competent authorities to develop robust regulatory strategies that are tailored to your specific needs. Our services include:
- Dossier Preparation and Submission: We specialize in the preparation and submission of veterinary dossiers, including New Animal Drug Applications (NADA) and Abbreviated New Animal Drug Applications (ANADA) to the US FDA.
- Labeling Compliance: We ensure that your product labeling meets all regulatory requirements for each target market.
- Pharmacokinetic and Bioequivalence Studies: We provide support for essential studies to demonstrate the safety and efficacy of your products.
- CMC Support: Our team offers comprehensive Chemistry, Manufacturing, and Controls (CMC) support to ensure product quality and consistency.
- Lifecycle Management: We provide ongoing post-approval support to help you maintain compliance and manage any changes to your products.
Your Trusted Partner in Animal Health
At DDReg Pharma, we are more than just a life science consulting firm. We are your strategic partner in navigating the complexities of the global veterinary regulatory landscape. We leverage advanced RegTech solutions for real-time regulatory monitoring and proactive risk management, helping you to streamline the approval process and minimize timelines. Our goal is to help you achieve your commercialization goals and bring safe and effective veterinary products to market.
Contact DDReg Pharma today to learn more about how our expert veterinary regulatory services can support your business.
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