Navigating the complex and ever-changing landscape of regulatory requirements can be a daunting task for any company seeking to develop and commercialize a new product.
That’s where our regulatory consulting services come in. We provide expert guidance and support to ensure that our clients meet regulatory compliance and achieve successful regulatory approval for their products.
Our experienced team of regulatory professionals offer customized solutions to address each client’s specific needs, from pre-clinical development to post-market approval, and everything in between. Trust us to help you successfully navigate the regulatory landscape and bring your product to market.
We provide comprehensive end-to-end support to guide you through the complex process of drug development and regulatory approval. This includes advising on project selection, product milestone setting, and project execution to help you achieve your development goals efficiently and effectively.
Our experienced regulatory experts can assist with all aspects of drug development, from preclinical research to clinical trials and ultimately, regulatory submission. We work closely with you to understand your needs and help you navigate regulatory requirements to ensure successful product development and approval.
We offer pre-submission review and editing of technical documents to ensure they meet regulatory standards. This includes reviewing Quality Overall Summary (QOS), Product Development Reports (PDR), Module 3, and other relevant documents. Our team of experts will work with you to ensure that your documents are clear, concise, and comply with relevant guidelines and regulations. With our support, you can be confident that your technical documents are of the highest quality and ready for successful submission to regulatory authorities.
Dossier audit (Module 1 to Module 4) is a critical aspect of regulatory consulting, as it ensures that all aspects of the regulatory submission package are complete and accurate.
Our team of experts will meticulously review and audit all the relevant documents related to the regulatory submission package. This includes evaluating the completeness of the dossier, ensuring accuracy and consistency of data, and verifying that all regulatory requirements have been met. We will provide a detailed analysis of the dossier, identifying potential gaps and inconsistencies, and offer recommendations for corrective action if necessary.
With our thorough and comprehensive audit, you can be confident in the completeness and accuracy of your regulatory submission package.
Assisting in FDA deficiency letter response is a key service we offer as part of our regulatory consulting services. We provide support and guidance to our clients in responding to various types of FDA deficiency letters, including information requests (IRs), discipline review letters (DRLs), and complete response letters (CRLs).
Our team of experts can help clients understand the nature of the deficiencies identified by the FDA, prioritize and develop appropriate responses, and prepare and submit high-quality response documents. Our aim is to help our clients achieve timely and successful resolution of regulatory issues, and to facilitate the approval and launch of their products in the market.
New Jersey
259 Prospect Plains Rd
Cranbury, NJ, 08512
732.783.7398
bd@accurantbiotech.com
Shanghai
Room 505, Floor 5
No. 8, Jiafeng Rd.
Free Trade Zone
Shanghai, China
Ningbo
Floor 4, Building A5
No. 587, Juxian Rd.
High-Tech Zone
Ningbo, China
Want more information?
Feel free to contact me, and I will be more than happy to answer all of your questions.