Veterinary / Feeds
We at RAAJ GPRAC manage the Complexity of Compliance involved in meeting regulatory requirements for the successful development and timely approval of new veterinary drugs. We offer a broad range of regulatory, clinical, and animal safety experience. Our experienced team is uniquely positioned to give you a view of what to expect every step of the way.
The animal feed sector is highly regulated and requires a high level of technical expertise to support the complex business environment. Our team have decades of experience in all areas of feed. We have inspected and supported feed mills. We can help your business with product positioning, proof of concept, technical communications and with valuations for acquisition and divestiture.
Services Pertaining to Veterinary
- Regulation Framework: Craft a well-defined strategy that is compliant with regulations
- Support preparation for pre-submission meetings with regulatory agencies
- Maintain timelines and budget throughout all development stages, manage risk and avoid pitfalls.
- Expert reports and an update to a health risk assessment for an over-the-counter veterinary product
- Non-active formulation components and additives are evaluated for hazard and risk.
- Contaminants in animal feed are evaluated for their potential to cause harm.
- Assist in study design and protocol development.
- Manage your clinical development program
- Help to keep your approved dossiers current
- Design, planning and completion of CMC and cGMP strategies
- Assist in preparation and submission of annual reports and manufacturing change supplements to meet regulatory requirements.
Services Pertaining to Animal Feeds:
- Feed additive registration
- Feed compliance strategy
- Set up of regulatory and quality management systems
- Compound/ Complementary Feed/ Premix/ Additives labelling
- Pet food labelling
- CLP advice and labelling
- Crisis management systems and support
- Handling of contamination and notification issues
- Applications to run trials using non-authorised additives
- Brexit advice for feed business operators
- Product claims