Akums has a team of Regulatory Specialists who are dedicated to ensuring compliance with the rigorous standards and regulations in the pharmaceutical industry, guaranteeing the quality and safety of products.
The Regulatory Department is an expert in keeping up with changing regulations. We guide and offer wide range of RA capabilities to add value to new and existing clients throughout their product journey.
Work with us on scientific advice, regulatory strategy, meetings with regulatory agencies, requests on required information and post-approval work. Thanks to our extensive experienced Team, we can provide you with an understanding of all regulatory requirements.
Our team works with industry organizations to support and propose innovative solutions that facilitate updated scientific path to accelerate clinical drug processes and mitigate differences in interpretation of global product documentation requirements in commercial approval processes.
We provide comprehensive regulatory filing and documentation services to ensure compliance with global regulations and standards, streamlining the approval process and ensuring timely market access of the products.
Akums seek guidance from regulatory agencies to strengthen quality systems, ensuring compliance with regulations and standards, building capacity for local manufacturing, and improving access to safe and effective medicines for patients.
Our team of regulatory experts is constantly monitoring and analyzing the changing regulatory landscape, which is constantly evolving and challenging. We utilize innovative solutions and strategies to keep up with these changes and ensure that we remain at the forefront of regulatory compliance. We are constantly updating our processes and procedures, adapting and evolving with the industry in order to stay relevant and meet the demands of the constantly changing regulatory climate.
Our ability to stay informed and proactive approach gives us an edge and puts us in an ideal position to meet the requirements of regulators, clients, partners, and stakeholders.