Looking to penetrate new markets with your medical products or devices? We are your end-to-end regulatory partners from initial idea to market approval.
All-inclusive regulatory management services throughout your product’s entire lifecycle.
We provide a wide range of services to help you navigate the regulatory landscape and ensure compliance with industry standards.
- Regulatory Intelligence
- Keeping up-to-date with the latest regulations and standards.
- Regulatory Strategy
- Developing plans to navigate regulatory requirements efficiently.
- Consultation Meetings
- Facilitating interactions with health authorities.
- Regulatory Operations
- Managing the practical aspects of compliance and submissions.
- Clinical Trial Operations
- Overseeing the administration of clinical trials.
- Medical Writing and Publishing
- Creating necessary documentation and reports. Performing technical document translations.*
- Product Registration
- Handling the registration of drugs, medical foods and medical devices with the relevant government and regulatory authorities.
- Product Life-Cycle Management
- Ensuring compliance throughout a product's life cycle.
- Pre-Submission Meetings
- Preparing for meetings with regulatory bodies.
- Post-Approval Changes
- Managing changes to a product after it has been approved.
Areas We Serve
United States
For the US market, we specialize in facilitating New Drug Application (NDA) filings and Abbreviated New Drug Application (ANDA) filings. We ensure that pharmaceutical companies can quickly and efficiently submit their applications for new drugs or generic versions of existing drugs. For NDAs, we meticulously compile comprehensive information on safety, efficacy, labeling, manufacturing processes, and quality controls. When it comes to ANDAs, we focus on ensuring that bioequivalence is demonstrated to reference drugs in your submission. Our goal is to support the continuous evaluation and improvement of the pharmaceutical landscape, helping companies make safe and effective medications accessible to patients across the United States faster.
China
For the Chinese market, we specialize in facilitating New Drug Applications (NDAs). Our expertise ensures that pharmaceutical companies can efficiently submit their applications for new chemical drugs, new biological products, gene and cell therapies, new vaccines, and new traditional Chinese medicines approved for the first time in mainland China. Notably, China set a new record in 2023 by approving the highest number of new drugs in a single year—104 in total. These approvals encompassed a wide range of therapeutic areas, including oncology drugs, anti-infective drugs, and central nervous system (CNS) drugs. Additionally, we make sure that companies can effectively use the expedited regulatory pathways for rare disease drugs and pediatric drugs, addressing unmet clinical needs and ensuring that innovative treatments reach patients efficiently.
We are here to assist you with any questions or inquiries you may have. Whether you are looking for more information about our services, need support, or want to provide feedback, please feel free to get in touch.
Please email us and we will keep you closely updated on new regions and new additions to the scope of our services.
*Currently, we only service products intended for US & China markets and offer document translations between English and Mandarin Chinese.
- Address
- 350 Wireless Blvd. Hauppauge, NY 11788
- info@regulen.com