FAQ – Intelur Pharma Science Private Limited


Intelur Pharma is a premier pharma and Biopharma regulatory services provider. We offer a comprehensive range of services including regulatory strategy development, dossier preparation, clinical trials support, compliance consulting, post-approval changes and more. Our expertise covers various areas such as CMC, clinical regulatory affairs, medical writing, agency negotiation and quality speedy approvals.

The team at Intelur Pharma consists of highly qualified professionals with over 30+ years of experience in the pharmaceutical and Biopharmaceutical industry. Our leadership team and subject matter experts have extensive knowledge and expertise in regulatory affairs, ensuring that we deliver exceptional regulatory support to our clients.

At Intelur Pharma Science, we prioritize regulatory compliance and ensure that our clients meet the necessary requirements. We have a deep understanding of global regulatory frameworks, guidelines and best practices. Our team stays updated with regulatory changes and developments, allowing us to provide effective strategies to navigate complex regulatory landscapes and mitigate risks.

We understand the importance of client data security and confidentiality. At Intelur Pharma, we have robust systems and processes in place to protect sensitive information. We adhere to stringent security protocols and industry best practices to ensure the confidentiality and integrity of client data throughout our engagement.

Yes, Intelur Pharma serves clients globally. We have experience working with regulatory authorities worldwide and can provide guidance on international regulatory requirements. Our global reach enables us to assist clients in achieving market access in various countries and regions.

To get in touch with Intelur Pharma, you can visit our website at www.intelurpharma.com and fill out the contact form. Alternatively, you can email us at contact@intelurpharma.com. Our team will be happy to assist you and address any further inquiries you may have.

Intelur Pharma primarily serves the pharmaceutical, Biopharmaceutical and Medical Devices industries. We provide regulatory services to companies involved in the development, manufacturing and distribution of pharmaceutical products, including small molecules, biologics, biosimilars and advanced therapy products.

Yes, Intelur Pharma has experience in regulatory submissions for various countries. We can help clients navigate the regulatory requirements and guidelines specific to different regions and assist in preparing and submitting regulatory dossiers for Market authorization applications (MAA), New drug applications (NDA Abbreviated), abbreviated new drug applications (ANDA) and other regulatory submissions globally.

Intelur Pharma has a dedicated team that continuously monitors and tracks regulatory changes, updates and industry trends. We actively engage in regulatory networks, participate in industry conferences and collaborate with regulatory authorities to stay informed about the latest developments. This enables us to provide up-to-date guidance and ensure compliance with the evolving regulatory landscape.

Yes, Intelur Pharma offers regulatory consulting services for Orphan Drug Designations (ODD). We can guide clients through the process of obtaining ODD status for their products, including assistance in preparing the necessary documentation, conducting gap analyses and liaising with regulatory authorities to support the ODD application and approval process.

Yes, Intelur Pharma offers regulatory compliance consulting for post-approval changes. We can assist clients in assessing the impact of proposed changes, preparing the necessary documentation and navigating the regulatory requirements for submitting post-approval change applications. Our expertise ensures that the changes are implemented while maintaining compliance with applicable regulations.

Absolutely! Intelur Pharma can assist in developing regulatory strategies for product launches. We analyze the regulatory requirements, target markets and specific product characteristics to provide tailored strategies that optimize the chances of successful product launch and market access. Our expertise helps clients navigate the complexities of global regulatory frameworks to ensure a smooth and efficient launch process.

No. 6, 2nd Floor, 30th Main Road, College Teachers HBCS, BDA, Banashankari 3rd Stage, Bengaluru-560085, Karnataka, India

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