The team of Dr. Mukul Agrawal and Dr. Shehla Uraizee has a proven track record of working with clients to successfully develop products for US FDA approval. These include various dosage forms such as oral solids and liquids, injectable, transdermal, nasal and inhalation products. Whether it is a complex dosage form or a combination product, ANDA or 505(b)(2), you can rely on our expertise to guide you to a successful outcome.
Our extensive experience in 505(b)(2) covers both new formulations and new approvals of marketed but unapproved drug products. We assist in development of regulatory communications including PIND meeting request letters, PIND meeting briefing package, literature reviews and summaries, product development strategies and representing clients throughout the pre-NDA process.
Please browse through the individual pages for Dr. Agrawal and Dr. Uraizee to gain a better understanding of their backgrounds and their areas of expertise.
Feel free to contact us today and we will be happy to discuss your specific requirements and how we may collaborate with you for a successful implementation of your goals.