Celerion’s Regulatory Affairs team can help you plan the right development strategy for your drug product as well as support the drafting and submission of key regulatory documents to the Food and Drug Administration (FDA) and Medicines and Healthcare products Regulatory Agency (MHRA). Our regulatory experts ensure quality documentation preparation and seamless guidance across the drug development lifecycle.
Our experienced global regulatory team helps you plan and execute practical regulatory strategies with tactical support to meet your objectives, yield high-quality regulatory documentation, and ensure timely communication with regulatory agencies in the US and UK for:
Investigational new drug (IND) application submission
Clinical trial application (CTA) submission
New Drug Application (NDA) submission
Abbreviated New Drug Application (ANDA) submission
Since 2010, we have supported over 100 IND applications. Our team brings more than 30 years of combined clinical trial experience. With fully integrated regulatory, scientific, and operational expertise, we offer comprehensive support throughout the drug development process.
Integrated drug development requires a multidisciplinary approach to understand how manufacturing, pharmacology, and toxicology contribute to your regulatory strategy and to elements of clinical study design and conduct. The knowledge and leadership of our highly trained scientists significantly streamline the early clinical development process, enabling you to minimize costs and make better-informed decisions. Our integrated services and expertise span small and large molecule drugs, and other therapies, from nonclinical testing through clinical proof-of-concept.
Our drug development experts can provide a ‘gap analysis’ and provide technical advice. Clients regularly tap into our clinical pharmacology expertise and clinic capacity to design and execute efficient, timely packages of studies that support drug product labeling, including drug-drug interactions (DDIs), PK in patients with hepatic or renal impairment, ADME, and market product bioequivalence.
Preparing for an initial IND filing can be a complex, time-consuming, and labor-intensive process. It involves gathering extensive data from nonclinical studies, manufacturing processes, and clinical research plans, all of which need to be meticulously documented and presented in a comprehensive manner. Regulatory requirements must be thoroughly understood and adhered to, ensuring that every detail meets the stringent expectations of regulatory authorities. Using regulatory experts with experience in IND and NDA management to oversee the authorship, compilation, and submission process can help ensure an efficient and seamless submission. Our team of experts are well-versed in the intricacies of regulatory guidelines and have the expertise to navigate potential challenges, thereby minimizing delays and errors.
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