Regulatory Affairs & Compliance

Navigating the complex and ever-evolving global regulatory landscape is critical for successful clinical development. ABS Clinical Solutions provides expert regulatory affairs and compliance services to guide your product from early development through to market approval and post-marketing commitments. Our regulatory specialists possess in-depth knowledge of regulations from key health authorities, including the FDA (USA), EMA (Europe), CDSCO (India), and others. We assist with the preparation and submission of various regulatory documents, such as Clinical Trial Applications (CTAs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and their amendments. We also provide strategic regulatory advice, conduct regulatory intelligence, and ensure ongoing compliance with Good Clinical Practice (GCP) and other relevant guidelines. Our goal is to streamline your regulatory processes, minimize delays, and ensure that your clinical development programs meet all necessary legal and ethical requirements, facilitating timely product approvals.