At Piramal, we view Quality as a collective responsibility integral to our organization, with an independent reporting structure to ensure true autonomy. Our stringent focus on Quality builds customer trust and strengthens our brand reputation. We have evolved from compliance-driven to culture-driven Quality, emphasizing systems, processes, technology, and people. Our strong governance is built on a three-tier quality process, which is aligned with business strategy and continuously improved through regular reviews.
We pride ourselves on impeccable data integrity standards, utilizing robust protocols and cutting-edge technology to ensure accurate, reliable, and secure data. Our commitment to leveraging artificial intelligence and automation has propelled our growth, particularly in management reviews, enabling quicker access to data and insights for informed decision-making. Our Quality Academy fosters continuous learning, keeping our team updated with industry trends and best practices, enhancing innovation and excellence. Proprietary quality tools guide us in risk navigation and leadership focus. We maintain unblemished inspection outcomes from regulatory agencies, including the FDA.
Our core strength is our high-performing team, which is regularly assessed and augmented for optimal resource utilization and career growth opportunities. Harmonized quality processes enable the successful handling of multiple integrated projects. Centralized strategies ensure consistent deliverables across all sites, driven by continuous learning and skill development, fostering a culture of innovation and excellence.
Regulatory Affairs services play a key role in ensuring that products are developed, registered and commercialized in adherence to the norms set forth by Health Authorities globally. This ensures speedy availability of safe and effective medications to patients. The business goals of the organization are also met due to timely product launches. Regulatory compliance throughout the product lifecycle is mandatory. Not many organizations have the privilege of having an expert regulatory team in house given their dedicated focus on developing much needed innovative and safe medicines.
Piramal’s regulatory team is well equipped to fill in this crucial gap. Our vision is to achieve "Right First Time" high-quality regulatory submissions, enabling fast-track product approvals and ensuring availability to patients. Our unique selling points (USPs) include a perfect blend of team members with prior experience in QA, QC, Production, Analytical, and R&D. We are customer-centric, providing open, transparent, and proactive submission management. Our regulatory skills encompass multiple countries' submission experience, keeping us abreast of the latest regulatory requirements. We are process-driven, with systems in place for confidentiality, SOP tracking, historical file archiving, and more. Each project is managed by an individual project owner to ensure focus and control. Additionally, our team possesses strong IT skills, expertise in eCTD submissions and Regulatory Information Management Systems.
We have achieved significant milestones, including extensive regulatory filings of NCEs (INDs, CTAs, IMPDs), successful submission of DMFs and MAAs (USA, EU, Canada, ROW countries). Our track record includes over 160 DMFs filed in various regions like USA, Canada, EU, Japan, China, Brazil, Korea and other countries. It also includes more than 20 CEPs filed with EDQM. More than 30 ANDAs filed with USFDA and a significant no. of approvals.
We excel in the preparation of regulatory strategies, extension of approved dossiers to various other markets, lifecycle management of drug substances and products, artwork preparation and management, and evaluating the regulatory impact of change controls. Our leadership in communication with Health Agencies, strong collaborative skills for client engagement, and effective cross-functional communication ensure quick turnaround times for query responses, guaranteeing customer satisfaction.
Piramal has a team of experienced pharmacovigilance professionals involved in providing end to end pharmacovigilance services. The team adheres to robust written procedures to deliver time bound results complaint to global regulations. The team of medical reviewers and health care professional are involved in through evaluation of data identified from various sources and evaluating risk benefit profile to highlight any risks. The team is also involved in working with clients on the mitigation strategy for any potential risk identified for patient safety.
Quality is the cornerstone of all the activities performed by Piramal team. A dedicated pharmacovigilance quality assurance team performs routine monitoring of all the key performance indicator to ensure compliance and upholds quality benchmarks. Their proactive anytime inspection readiness approach has contributed to favorable outcome to various pharmacovigilance inspections conducted by global health authorities.
The enabler for the services includes advanced technology platforms, efficient intelligent automations, trained teams, knowledge and experience in global regulations, network of vendors to meet any local requirements globally. The governance mechanism and the oversight reports provided by the Piramal would ensure that the client has complete visibility into all the activities performed by Piramal pharmacovigilance team.
Our PPDS, Ahmedabad facility has a state of art Analytical Services lab engaged in analytical method development, validation and method transfer for OSD products. More than 1150 analytical methods have been developed and validated. The team has highly experienced scientists having the best skill set to develop methods for simple to complex drug products. Single method for assay, dissolution and impurities for foxed-dose combinations have been developed and validated saving resources and time for our clients.
This lab has technical capabilities for risk assessment, method development and validation of Nitrosamine Impurities. Equipment like HRMS, LCMS, and GCMS allows us to identify the smallest amount of these impurities in API and Drug Products. This facility also have capability of Impurity Characterization, which helping our clients in the critical stages of drug product development. In the NCE development, we have supported our clients with identification, isolation and structure identification of unknown impurities observed during the development phase of different clinical stages.
We are also extending support to our clients in method development, validation, and evaluation of “Elemental Impurities” by ICPMS in the drug product. We also have the capabilities to conduct method development, and validation of Extractable and Leachable of different container and closer system. We can also perform solid-state characterization of API and we have the best equipment to support these studies. We have the expertise of polymorphism study, Salt screening of API to identify the best and stable salt for drug product development. XRPD (Bruker), TGA, DSC, Hot-Stage microscope.
