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Aptuit Consulting receives FDA approval for Electronic Submissions
Paper-based regulatory dossiers are drawing to a close; regulatory dossiers in electronic format are a key business offering that will facilitate rapid review and approval in the global Bio-pharmaceutical marketplace.
The Aptuit Consulting Regulatory Team took a big step towards providing clients with a set of services allowing them to submit and manage US regulatory documents in eCTD (electronic common technical document) format. Our team recently provided a test submission to the FDA that was expeditiously accepted. The successful completion of this milestone now allows Aptuit Consulting to submit client reports to FDA in eCTD format.
Our Regulatory Submission Services are delivered by highly experienced publishing professionals who understand the regulatory requirements and are committed to completing projects on time.
Aptuit Consulting will be holding a free webinar to highlight this new service and will provide an overview of the eCTD regulatory requirements. If you would like to sign up or obtain more information please click here.
A Global Service
Aptuit is a drug development and pharmaceutical services company conducting research, development and manufacturing on a global contract basis for both large and small innovators.
Our mission is to engineer a better drug development process to provide solutions to our clients’ diverse and differing program needs.
Our complete suite of pharmaceutical services enables the client to realise their drug development program from proof of concept through to launch and delivery.
Aptuit INDiGO™ compresses these timelines still further delivering API to IND in just 26 weeks.
Click here to discover how our services can assist you.
- Preclinical and Clinical Technologies: An Overview
Preclinical and clinical activities are crucial to your submission of a successful IND. We help guide clients through the discovery process and provide services based on our superior technologies, state-of-the-art facilities, and globally-recognized expertise to help bring your drugs to trial faster.- Aptuit completes acquisition of SSCI, integrating industry-leading solid-state chemistry services into its offering. >>
- Aptuit Consulting: An Overview
We recognize that the drug development process has become increasingly complex, costly, and time-consuming. Our consulting team is comprised of industry veterans who have guided successful drug candidates down the development path many times. These highly experienced scientific managers steer you through the complex regulatory framework and provide valuable insight to achieve the most cost-effective, success-oriented outcome. We will successfully guide you through the drug development process and help get your new product to market.- Our team is comprised of industry veterans who have guided successful drug candidates down the development path many times. >>
- Aptuit Informatics: An Overview
Aptuit Informatics provides best-of-breed, mission-critical information system capabilities to help clients navigate the clinical supply chain. We are dedicated to delivering the industry’s first seamless IT system across all steps in the drug development process to enable end-to-end, customer-accessible project management and test data that eliminates repetition, rework, and renew.- Learn more about our Clinicopia Suite®, the world’s first purpose-built, industry-specific clinical trial supply management suite. >>
- Pharmaceutical Sciences: An Overview
At Aptuit, we know that pharmaceutical development is one of the most challenging and multifaceted aspects of all business ventures. Our network of highly skilled specialists and global capabilities can help you address numerous regulatory requirements while navigating through the complexities of pharmaceutical science and manufacturing.- Our stability testing and sample storage provides you with comprehensive programs for fully validated storage environments. >>
- Active Pharmaceutical Ingredients: An Overview
Aptuit recognizes that the pharmaceutical industry is globalizing and faces increasingly stringent regulations, creating a demand for high-quality active pharmaceutical ingredients (APIs). Aptuit offers a broad range of services that allow you to establish and maintain tight control over your API process development.- Aptuit completes acquisition of EaglePicher Pharmaceutical Services, adding API development and manufacture to its suite of services. >>
- Clinical Packaging and Logistics: An Overview
Clinical supply chain management and logistics is becoming increasingly complex, global, and multi-faceted. With more than 600,000 sq. ft. of capacity, 30 international clinical distribution sites, and the best end-to-end IT solution available, our unsurpassed attention to detail drives projects to completion cost-effectively and with the highest level of client service in the business.- Scott Houlton, President of CPL, explains how automated systems and lot genealogy can improve efficiency in the supply chain. >>
- Aptuit Laurus: An Overview
Here at Aptuit Laurus we combine Aptuit's global offerings in drug development with Aptuit Laurus' R & D and manufacturing expertise, operating from newly built state-of-the-art facilities. Aptuit Laurus provides established and emerging pharmaceutical companies with integrated services, technologies and manufacturing capabilities that span the entire drug development continuum including the core disciplines of R & D solutions and drug substance manufacturing.
Focus on... |
Aptuit INDiGO™
Learn how Aptuit can accelerate your drug development process. Play the Aptuit INDiGO™ race game now!
Our complete suite of services supports and promotes the drug development process, enabling each client to differentiate their program effectively and within a suitable cycle-time:
