KNORS Pharma Solutions LLP

Who We Are

Welcome to KNORS Pharma Solutions LLP, a pioneering name in the realm of drug regulatory affairs consulting services in India. Based in Chandigarh, we are a team of dedicated professionals who specialize in navigating the complex landscape of pharmaceutical regulations. Our experts have been recognized on global platforms and boast approvals from several developed countries including Canada, America, the United Kingdom, and Europe. At KNORS Pharma, innovation and transformation are not just buzzwords but integral aspects of our approach to regulatory affairs. Our mission is to support pharmaceutical companies by ensuring compliance with ever-evolving regulatory norms, thereby facilitating the smooth approval of their products.

What We Do

At KNORS Pharma, we offer comprehensive regulatory affairs consulting services tailored to meet the unique needs of pharmaceutical companies. Our services include:

• Drug Master File Dossier Compilation: We specialize in compiling dossiers for DMF, ASMF, APIMF, CESP, and ANDAs.
• eCTD Format Publishing: Utilizing advanced software, we publish dossiers in eCTD format to ensure seamless submission to regulatory agencies.
• Regulatory Compliance: Our experts assist companies in addressing deficiencies highlighted by regulatory agencies during the review process.

Our structured approach ensures that we maintain clear communication channels between pharmaceutical companies and government bodies. This allows us to stay ahead of the curve by continuously updating our regulatory intelligence and methodologies.

Why You Should Use Us

Choosing KNORS Pharma means partnering with a team that is committed to excellence and innovation. Here’s why you should consider us for your regulatory affairs needs:

• Global Recognition: Our methods and practices have earned us approvals from leading regulatory bodies worldwide.
• Expertise: Our team comprises seasoned professionals, including former FDA consultants and experts with extensive knowledge of FDA reforms.
• Innovation-Driven: We constantly upgrade our techniques and stay abreast of the latest regulatory guidelines to offer cutting-edge solutions.
• Tailored Services for Startups: We provide specialized guidance for startups, helping them navigate risk factors and secure beneficial deals.
• Commitment to Quality: Quality assurance is at the heart of our services. We strive for excellence in every project, ensuring that our clients achieve prompt product approvals.

What Can You Ask?

We understand that navigating the complexities of drug regulatory affairs can be daunting. That’s why we’re here to answer any questions you may have. Here are some examples of what you can ask us:

• How can KNORS Pharma assist in compiling a Drug Master File (DMF) dossier?
• What are the benefits of publishing dossiers in eCTD format?
• How do you keep up with the latest regulatory guidelines and reforms?
• What kind of support do you offer for addressing deficiencies noted by regulatory agencies?
• Can you provide guidance for pharmaceutical startups?
• What makes KNORS Pharma stand out from other regulatory affairs consulting companies?
• How can we get started with your services?

Feel free to reach out to us with any other queries you might have. Our team is always ready to provide the information and support you need to succeed in the pharmaceutical industry.