As part of our CDMO operations, we offer differentiated products and services. Our in-house product strategy team is responsible for conceptualizing new formulations based on emerging epidemiological trends, global product approvals and opportunities within the pharmaceutical, wellness, and nutraceutical sectors. As part of the product conceptualization process, each prospective product undergoes rigorous clinical and stability studies, scale-up procedures, and a meticulous regulatory clearance process before launch.

OUR REGULATORY SERVICES INCLUDE A WIDE RANGE OF PRODUCTS

Pharmaceuticals
Nutraceuticals
Cosmetics
Derma

DRIVING REGULATORY COMPLIANCE COMPETITIVENESS

925+*

New Drug Approvals from D.C.G.I

Innovative Products

220+*

920+*

FSSAI Approvals

Patent applications filed

144+*

*the figures are till july 2024

OUR EXPERTISE

Dedicated Regulatory Specialists

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.

Understanding Regulation and Keeping Up With Dynamic Changes

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.

Strategic Development Support

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.

Supporting National Regulatory Framework

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.

Regulatory Filing and Documentation

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.

Partnering with Government To Strengthen Quality Systems

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.

CHANNELIZING THE CHANGING REGULATORY LANDSCAPE

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.

"Take advantage of our regulatory expertise to breathe easy on safety, compliance and regulation for the market."

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