Welcome to AARI
Your Trusted Partner in
Regulatory Excellence
At AARI, we specialize in delivering innovative and comprehensive regulatory deliverables to the pharmaceutical, biotechnology, and life sciences industries. We understand the complexities of the global regulatory requirements and are dedicated to guiding your business through every step of the compliance journey, ensuring your submissions reach the health authorities efficiently and successfully.
Welcome to AARI
Your Trusted Partner in Regulatory Excellence
At AARI, we specialize in delivering innovative and comprehensive regulatory deliverables to the pharmaceutical, biotechnology, and life sciences industries. We understand the complexities of the global regulatory requirements and are dedicated to guiding your business through every step of the compliance journey, ensuring your submissions reach the health authorities efficiently and successfully.
What Sets Us Apart?
Tailored Solutions for Every Client
Our team works closely with you to develop customized strategies that align with your business goals and regulatory requirements.
Global Expertise, Local Understanding
With a deep understanding of regulatory frameworks across major markets, including the US, EU, ANVISA, GCC and APAC regions, we bridge the gap between global expectations and local nuances.
End-to-End Support
From regulatory strategy development to eCTD publishing, SPL and labeling, writing sections, and registrations, we offer a full suite of services to meet your needs.
Commitment to Excellence
With a team of experienced professionals, cutting-edge technology, and a passion for delivering results, we ensure your projects are handled with precision and care.
What We Do
At AARI, we specialize in delivering comprehensive and tailored solutions across a broad spectrum of pharmaceutical and regulatory needs, including:
Regulatory Submissions and eCTD Publishing
Expertise in preparing and submitting DMFs, CEPs for EDQM via CESP, ANDAs (505j & 505b(1)(2)), European filings (DCP, MRP, National procedures), WHO prequalification, and China filings.
Mastery in eCTD publishing and submission for seamless global compliance.
Comprehensive Project Management
From regulatory filings and lifecycle management to compliance and IT solutions, we manage every aspect of your pharmaceutical project with precision.
Regulatory Strategy and Expertise
Devising effective regulatory strategies and offering technical guidance to streamline complex procedures.
Writing quality modules for DMFs, ASMF’s, dossiers, and other regulatory documentation.
Global Regulatory Support
Acting as a country representative and drug listing agent for regions including the USA, EU, India, and more.
Pharmaceutical IT Solutions
Providing cutting-edge, cloud-based systems with a focus on data security to meet the unique IT needs of the pharmaceutical industry.