Ensuring Global Compliance from Development to Commercialization
Stark Pharma offers comprehensive Regulatory Affairs services to help life sciences companies navigate complex global regulations across every stage of the product lifecycle. We support pharmaceutical, biotechnology, and medical device organizations with end-to-end regulatory strategy, dossier preparation, submissions, and compliance monitoring to meet regional and international standards.
We craft robust, market-specific strategies aligned with your product pipeline and timelines. Whether for pharmaceuticals or medical devices, our team designs the optimal regulatory approach to ensure timely approvals in the US, EU, India, and emerging markets.
Our experts specialize in compiling high-quality submissions, including CTD/eCTD for drugs and technical files for medical devices. We manage INDs, NDAs, ANDAs, MAAs, 510(k)s, CE Marking files, and more, ensuring adherence to ICH, FDA, EMA, CDSCO, and other global authority requirements.
We assist with the creation and review of product labeling and packaging to ensure regulatory compliance, clarity, and accuracy across regions and languages. Our team ensures your documentation aligns with evolving health authority standards.
We offer ongoing support for variations, renewals, and compliance updates to keep your product in-market and audit-ready. From labeling updates to manufacturing changes, we manage every detail of your product’s regulatory lifecycle.
Our services include regulatory classification, risk management, clinical evaluation report (CER) writing, and guidance through regulatory pathways like 510(k), PMA, CE Marking (MDR), and CDSCO registration for India.
Our team has a proven track record of successful submissions across major regulatory jurisdictions, with deep domain expertise in both pharmaceuticals and medical devices.
We ensure your product meets the latest regulatory expectations—whether it’s for a US FDA drug filing, a CE Mark for a device, or CDSCO approvals in India.
From early strategy and development to post-market maintenance, Stark Pharma is your regulatory partner through every phase of your product’s journey.
+1 (732)760-5152
hr@starkpharma.com
