Regulatory science is the technical foundation for regulations in various industries, particularly those involved in healthcare and safety. Regulatory sciences affect those who develop and comply with these regulations. It plays a significant role in scientific research and development.
Scicare is involved in every aspect of regulatory science, from its development to its strategic operation. We wish to enhance our operational efforts with strategies and aim to make a difference with scientific methodology.
Centre of Regulatory Excellence (CoRE)
We have established CoRE to provide unrivalled support in Global Regulatory Affairs with our unique capability to combine highly motivated regulatory professionals, process excellence, and technology. Our passion drives us to build partnerships for successful project outcomes.
Our core strength and focus areas include but not limited to:
● Regulatory Information Management (RIM)
● Publishing
● Global Labelling & Compliance
● Project management
● IDMP (Identification of Medicinal Products)
● Drug Listing
We aim to develop a unified technology interface that provides improved operational efficiency and a unique and seamless user experience. With our collaborative strategy management, we strive to strengthen the interaction between global and local modules.
Regulatory Information Management (RIM)
This system represents the life cycle process of a drug. With this information, various organisations develop new drugs and handle the existing products.
RIM helps enhance the standards of pharma regulatory information and effectively manages any query raised by the regulatory authority. However, due to increasing complexity in regulatory rules and procedures, organisations need to evolve with the changes. It demands extensive process mapping and support.
At Scicare, we provide support in system updates, information management, and error-free work. Our RIM experts are well-versed with different regulatory platforms. We help in strategizing, planning, managing, integrating, and updating data promptly. We utilize four core areas in our RIM support – People, Process, Technology, and Data.
Publishing
We provide a large variety of publishing services.
● Document and report-level publishing.
● Formatting in eCTD, NeeS, vNeeS, pCTD.
● Application formats such as ANDA, NDA, BLA, IND, NDS, SNDS.
● Conversion of existing format to eCTD.
● Submission filing, dossier planning, and strategy development.
● Training for core documents and submission publishing techniques.
Global Labeling Operations & Compliance (GLOC)
Our labelling experts manage global labelling operations from CCDS (Company Core Data Sheet) updates to notify affiliate markets using proactive well-planned metrics deployment and monitoring. We follow up with stakeholders and provide effective project management and successful execution.
At the core of every service, we ingrain compliance with defined internal standards, processes, and regulations.
We also provide labelling services like proofreading. We work with local labels such as SmPC, US PI, EU PI, and several others. Additionally, we offer clinical labelling, regional, and medical device labelling services.
Project Management
Project management is an approach to deliver a project throughout its life cycle. It involves scope management, project planning, execution and monitoring, timeline and budget planning and management.
At Scicare, we provide various tools and techniques such as Agile and Scrum for your efficient project management. We adapt to conditions and hone in our target incrementally.
IDMP (Identification of Medicinal Products)
IDMP consists of five standards developed within the International Organisation for Standardisation (ISO). These standards provide an internationally accepted framework for identifying medicinal products. It allows the exchange of regulated medicine product information.
At Scicare, our experts help you understand and implement this unique framework of identification. We guide you through the multifaceted process of standardisation and regulation of pharmaceutical products.
Drug Listing
Every drug that is imported or produced in the US requires registration and listing. This information plays a significant role in post-marketing surveillance, user fee assessments, and monitoring of drug shortages and availability. Every country has a unique system of drug listing that provides them with an organised surveillance system.
At Scicare, we connect you with the correct system to register your drug for listing. We help you understand the rules and regulations put forward by the concerned authorities.
With our Hybridge delivery models and cost-efficient services, we ensure the highest quality of service delivery for all your life science requirements. Contact us and get your healthcare assistance today!