ILS Life Sciences

Innovative Logic Solutions offers an interactive approach to global safety and pharmacovigilance. Our global Safety and Pharmacovigilance team has broad experience with a variety of databases and technology, in addition to concentrated experience with critically ill patients participating in global studies and numerous years of industry experience. Our Safety and Pharmacovigilance team excels at developing and maintaining interactive and multi-disciplinary relationships within the study team, with the goal of efficiently processing safety data by keeping key people involved and coordinating communications to sites to limit redundancy. This leads to rapid identification of any potential safety issues and resolution of any open events. The diligence and attention our sponsors receive from our Safety and Pharmacovigilance team is unique in the industry.

Innovative Logic Solutions’s Regulatory Affairs Professionals are dedicated to ensuring the successful and timely submission of your application. We work closely with you to provide strategic regulatory guidance toexpedite the compilation and submission of your applicationProduce a submission acceptable to local global regulatory authorities. Our Services include: 1. Regulatory Consulting 2. Regulatory Operations 3. Electronic Submissions/eCTD 4. Medical Device Classification and Strategy 5. Report preparation/publishing/submission 6. Regulatory Intelligence Center 7. Post-submission support (e.g., annual reports, amendments, variations)

Regulatory agencies across the world are moving to make electronic publishing following the Common Technical Document (CTD) format the preferred standard for submitting biologic and drug applications. Beyond this evolving regulatory requirement, the eCTD (electronic Common Technical Document) format also provides sponsors with the several benefits that: Innovative Logic Solutions E-publishing team understand that it takes more than document formatting, bookmarks and links to create an approvable FDA electronic submission. It requires content expertise — professionals who understand process, facility, and assay validation; who understand FDA expectations for preclinical and clinical data presentation and discussion; and who are familiar with the reviewer expectations in the various FDA review divisions.

Innovative Logic Solutions provides a broad range of Validation services in support of clients’ process, manufacturing, laboratory, and enterprise systems.We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical risk-based approach for validation Computer systems validation Innovative Logic Solutions provides a broad range of Computer System Validation (CSV) services, by verifying the controlled development and implementation of computer systems, we can help clients ensure the integrity, reliability, and availability of their regulated business data to support the production of quality products and protect patient safety. 1. System Requirements and design review 2. System development and verification (Installation qualification/ operational qualification/ performance qualification) 3. System operation (Data archiving/ Disaster recovery/ Back-up and Recovery) 4. Sytem Retirement (Data Migration strategies and verification) Process validation Through process validation, Cloud Data Systems Inc establishes documented evidence for our pharmaceutical, biotech, API and medical device clients to ensure process and product monitoring via consistently producing a product that meets its predetermined specifications and quality attributes. This process validation goes for all aspects of manufacturing, filling, sterilizing and packaging. We possess the knowledge of the critical processing steps, quality attributes and sampling strategies, which allows our Process Validation engineers to challenge the robustness of the process during the development and execution of the process validation studies. Product Performance Qualification- our goal is to help our clients every step of the way. That includes through product performance qualification. According to the FDA, the purpose of product performance qualification is: “to demonstrate that the process has not adversely affected the finished product and that the product consistently meets its predetermined specifications and quality attributes.” We offer consultancy in the following services: 1. FDA Process Validation 2. Process Performance Qualification (PPQ) 3. Guidance for Industry Process Validation General Principles & Practices 4. Process Validation Guidelines 5. GMP Process Validation

Our skilled teams of billing and coding experts have in-depth knowledge and hands-on experience on working with Medicare, HIPAA and Medicaid regulations. Our team has a thorough understanding of procedural and diagnostic coding, accounts payable management and electronic medical claims submission. Our skilled medical billing and coding experts are proficient with: ICD-9, ICD-10, CPT and HCPCS codes across different specialties Payer-specific medical coding requirements Governmental, regulatory and insurance requirements Our certified medical coders (CPC) keep themselves updated with constantly-changing trends in the medical industry, especially in ICD-9, CPT and HCPCS codes. We also stay current with the latest versions of medical coding software such as Encoder Pro and Flash Code. Staffing & Outsourcing Solutions: Innovative Logic Solutions is renowned for quality staffing and outsourcing services. Our customized staffing solutions match the personnel requirements of the clients. Your requirement for personnel may be on project basis or on turnkey basis, we are here to offer quality people and value-driven outsourcing processes for your business.