Our core mission is to empower people to live healthy, high-quality lives. We achieve this by providing a wide range of pharmaceutical and self-care products, including prescription medicines and cosmetics. We also invest in our people and the environment to support this goal.
We are continually consolidating our position as one of the leading pharmaceutical worldwide. Strengthening the long term bussinesss partnership in the fields of development, products supply and marketing. our long term aim is o pharma needs of mankind.
Our company culture is built on three pillars: innovation to advance patient care, achievement through excellence, and teamwork to foster collaboration and growth.
Catalent Life Sciences excels in advanced Formulation Development, leveraging cutting-edge technologies and deep scientific expertise to create innovative pharmaceutical and nutraceutical products. Our dedicated R&D teams specialize in overcoming complex formulation challenges, employing sophisticated techniques such as nano-suspensions, solid dispersions, and targeted delivery systems. We possess comprehensive capabilities in solubility enhancement, bioavailability optimization, and stability studies across diverse dosage forms, including injectables, oral solids, and novel delivery platforms.
Our state-of-the-art laboratories are equipped with advanced analytical instrumentation, enabling meticulous characterization and performance evaluation of formulations. We apply a QbD (Quality by Design) approach, ensuring robust and scalable processes from early-stage development through to commercialization. Catalent's commitment to scientific rigor and innovation drives the creation of differentiated products with enhanced therapeutic value and patient outcomes. We collaborate closely with partners, offering tailored formulation strategies and accelerated development timelines to bring novel therapies and advanced nutraceuticals to market efficiently.
The Regulatory Department at Catalent Life Sciences is responsible for strategically navigating the complex landscape of pharmaceutical and nutraceutical regulations to ensure the compliant development, registration, and lifecycle management of our products. Our experienced team provides comprehensive oversight throughout the entire product lifecycle, from preclinical stages through post-market surveillance, with an unwavering focus on meeting national and international regulatory requirements.
Specializing in regulatory affairs, we play a pivotal role in shaping product development strategy, preparing and submitting regulatory filings (NDAs, ANDAs, etc.), and engaging in crucial scientific communication with national and international health authorities, including CDSCO, USFDA, EMA, and others relevant to our target markets. Our expertise extends to interpreting evolving regulations, developing robust regulatory strategies, and ensuring timely approvals.
Our department comprises highly qualified professionals, many holding advanced degrees, who possess extensive experience in regulatory submissions, compliance, risk assessment, and interactions with regulatory agencies. This deep expertise enables close collaboration with cross-functional teams, providing critical regulatory guidance to areas such as formulation development, manufacturing, quality assurance, pharmacovigilance, and market access. Our core mission is to ensure the safety, efficacy, and quality of our products while adhering to the highest regulatory standards, ultimately safeguarding patient health and facilitating access to essential medicines and nutraceuticals.
Catalent is dedicated to developing innovative products and technologies within the pharmaceutical industry. To safeguard the significant value of the intellectual property generated in our laboratories, we have built a comprehensive international patent portfolio.
We hold over 100 patents and patent applications across more than 50 countries, securing key products and technologies, including, but not limited to, formulations for controlled drug release systems.
Catalent’s supply chain for pharmaceutical products is seamlessly integrated, ensuring full traceability and monitoring at every stage. From reception and identification to storage, order preparation, documentation, shipment, and distribution, we ensure the highest standards of quality and compliance with authorized storage conditions.
With extensive experience in shipping temperature-sensitive products worldwide, we specialize in handling a variety of conditions, including ambient temperature (<25ºC). We partner with leading suppliers of both active and passive temperature control systems, selecting the most suitable solutions for each shipment to guarantee the quality of the final product upon arrival.
Catalent also takes full responsibility for preparing export documentation in accordance with the regulations of each destination country, streamlining the import process for customers and ensuring prompt and efficient shipping.
Our customer service team, both domestically and internationally, closely monitors every step of the sales process—from order receipt to final delivery—ensuring the highest level of service and customer satisfaction. We are committed to providing exceptional service by focusing on attention to detail and maintaining a deep understanding of the unique needs of each client.
Catalent’s Regulatory Affairs team has extensive expertise in global registration procedures, with a particular focus on the European market (NP, DCP, CP, MRP) and the United States. Our team also provides comprehensive support for registration procedures across other key regions, including Canada, Australia, ASEAN, APAC, MENA, LATAM, and more.
Catalent's core regulatory capabilities include:--
- Preparation of new dossiers in e-CTD format
- Audits of registration dossiers and DMFs
- Management of authorization processes and updates to registration dossiers across various regions
- Regulatory support for clients navigating procedures in different territories
