Our Accomplishments in Regulatory Submissions

At Catain , we take pride in delivering high-quality, compliant, and timely regulatory submission services that help pharmaceutical companies achieve successful approvals with the U.S. Food and Drug Administration (FDA). With over a decade of proven expertise, Catain has built a strong reputation as a trusted partner for both local and international clients.

Proven Track Record of FDA Submissions
Over the past 10 years, Catain has successfully managed a wide range of regulatory submissions in eCTD format, ensuring accuracy, compliance, and seamless delivery through Catain’s FDA gateway:
• 3 approved 505(b)(2) Applications – demonstrating expertise in complex drug development strategies.
• 10 Investigational New Drug (IND) Applications – supporting clients from preclinical to first-in-human trials.
• 50+ Abbreviated New Drug Applications (ANDAs) – guiding generic drug approvals across multiple dosage forms.
• 10+ Drug Master Files (DMFs) – prepared and submitted for APIs.

✅ All submissions were meticulously prepared, reviewed, and submitted in full compliance with FDA requirements.

Global Client Portfolio & Active Projects
Catain is currently managing a diverse portfolio of more than 40 active projects across U.S., European, and Asian markets. Our client base includes emerging pharma startups, mid-sized pharma companies, and global leaders.

By offering end-to-end regulatory solutions, we help clients accelerate development timelines and navigate complex regulatory pathways with confidence. 

Round-the-Clock Global Support
With dedicated teams in the United States and India, Catain provides 24/7 regulatory support, ensuring that critical submissions and responses are delivered without delay. This global presence allows us to work efficiently across time zones and support clients in multiple regions.

Expertise Across All Dosage Forms
Our experience spans a wide variety of product types, including:
• Oral solid dosage forms – tablets, capsules
• Oral liquid dosage forms – solutions, suspensions
• Sterile and parenteral products – injectables
• Specialty products – ophthalmic, nasal formulations, and more

✅ This broad experience positions Catain as a trusted partner for generic, innovative, and complex drug submissions.

Why Choose Catain ?
• 10+ years of regulatory excellence in FDA submissions
• Proven expertise in 505(b)(2), IND, ANDA, and DMF submissions
• Global reach with teams in the U.S. and India • Comprehensive services from strategy to submission
• Client-focused approach delivering compliance, quality, and speed

Partner With Us
Catain is committed to helping pharmaceutical companies bring safe and effective medicines to patients faster. Whether you are preparing your first IND, planning a 505(b)(2) strategy, or managing a global ANDA portfolio, our team has the expertise to ensure regulatory success.

Contact us today to learn how Catain can support your next FDA submission.