Regulatory Approval

Rest assured, Oakley Business Development is a trusted partner with a proven track record of success in regulatory submissions. We have achieved remarkable outcomes for numerous clients, including securing approvals from esteemed regulatory bodies such as the US Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) and New Drug Application (NDA), as well as the European Medicines Agency (EMA) for Marketing Authorization Application (MAA) and Medical Device Regulation (MDR).

Our expertise lies within Module 3, or CMC (Chemistry, Manufacturing, and Controls) matters, where we have honed our skills to perfection. We are fully equipped to guide you through the intricacies of the regulatory process, providing expert advice on the optimal submission route. Furthermore, we offer pre-submission readiness evaluations, ensuring that your submission is well-prepared and positioned for success.

With Oakley Business Development by your side, you can trust that our pharmaceutical development projects are specifically tailored to deliver the precise data set required for successful submission and validation. We understand the importance of adhering to regulatory requirements, and our meticulous approach ensures that your submission is comprehensive, robust, and compliant.

Rest easy knowing that Oakley Business Development is your reliable ally throughout the regulatory journey. We bring reassurance, expertise, and an unwavering commitment to excellence. Let us navigate the complexities of Module 3 and guide you towards regulatory success, instilling confidence and peace of mind at every step.