About DDReg Pharma Pvt Limited
DDReg Pharma Pvt Limited: Your Trusted Partner for Global Regulatory Solutions
DDReg Pharma Pvt Limited is a leading provider of global regulatory solutions, regulatory consulting services, and pharmacovigilance services to pharmaceutical, biotech, and medical device companies worldwide. With a team of experienced professionals who are well-versed in the complex regulatory landscape, DDReg Pharma offers tailored solutions to meet specific needs.
The company's core focus is on providing comprehensive regulatory support to clients throughout the product lifecycle. From early-stage development through post-marketing activities, DDReg Pharma provides expert guidance on all aspects of global regulatory compliance. The company's services include:
1. Regulatory Strategy: DDReg Pharma helps clients develop effective strategies for navigating the complex global regulatory environment. The company's experts provide guidance on product development plans, clinical trial design and execution, and pre-market approval requirements.
2. Submission Management: DDReg Pharma assists clients with preparing high-quality submissions that meet all relevant regulations and guidelines. The company has extensive experience in preparing INDs/CTAs/NDAs/BLAs/PMA submissions across various therapeutic areas.
3. Safety Reporting: DDReg Pharma provides comprehensive pharmacovigilance services to ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs) as per local regulations.
4. Compliance Support: DDReg Pharma helps clients maintain compliance with applicable regulations by conducting gap analyses against current practices or standards such as GxP/GLP/GMP/GCP/GDP etc., developing SOPs/WIs/TMs etc., conducting internal audits or mock inspections etc.
DDReg Pharma understands that every client has unique needs when it comes to navigating the complex world of global regulation; therefore they offer customized solutions tailored specifically for each client's individual requirements.
The team at DDReg Pharma comprises highly qualified professionals with extensive experience in their respective fields such as Regulatory Affairs (RA), Quality Assurance (QA), Pharmacovigilance (PV), Clinical Development, and Medical Writing. The company's experts have a deep understanding of the regulatory requirements across various regions such as US FDA, EU EMA, Health Canada, ANVISA Brazil, TGA Australia etc.
DDReg Pharma is committed to providing high-quality services that meet or exceed client expectations. The company's focus on quality is reflected in its ISO 9001:2015 certification for Quality Management System (QMS) and ISO 27001:2013 certification for Information Security Management System (ISMS).
In conclusion, DDReg Pharma Pvt Limited is a trusted partner for navigating the complex regulatory landscape. With its team of experienced professionals and customized solutions tailored to meet specific needs, DDReg Pharma helps clients bring their products to market quickly and efficiently while maintaining compliance with all relevant regulations. Contact DDReg Pharma today to learn more about how they can help your organization achieve success in the global marketplace!
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