"I love Kymanox | Your Premier Life Science Solutions Partner "

2022-07-16 22:26:57

+1 919 246 [email protected] in Touch HomeSolutionsDevelopment & OperationsProduct & Process DevelopmentCMC Services & Analytical SciencesProcess EngineeringMS&T & Supply ChainHuman Factors Regulatory & Strategy (HURAS)Packaging Technology & EngineeringQuality, Regulatory, & ComplianceQuality Assurance, Compliance & AuditingQuality EngineeringQuality ControlRegulatory AffairsClinical & Medical AffairsCGxP Microbiology & Environmental MonitoringCommissioning, Qualification, & ValidationValidation Master PlanningFacilities & Utilities CQVLab & Equipment CQVComputer System Validation (CSV)Process ValidationCleaning ValidationStrategy, Planning, & ExecutionProgram & Project ManagementTechnology TransferInnovation SolutionsEnterprise Resource Planning & SolutionsDue DiligenceStaffing SolutionsMarketsCombination ProductsBiologics and Cell & Gene Therapy ServicesPharmaceuticalsOtherAboutMeet the TeamInfo SheetsKymanox CaresCase StudiesTestimonialsPast PerformanceUpcoming EventsInsights .custom-menu > ul > li > a {background: var(--c-text-primary);} Accelerate development and delivery of your modern medicines Kymanox makes it easy for life science teams to get more done Connect With Kymanox Scroll We are a Modern Life Sciences Consulting Company that Acts as an Extension of Your Team The breadth of our experience allows us to tackle any modern medicine development & commercialization challenge Start Getting More Done 01Development & OperationsBring your product to market in a timely fashion 02Quality, Regulatory, & ComplianceEnsure the safety and compliance of your product 03Commissioning, Qualification, & ValidationKeep your facilities and equipment running properly 04Strategy, Planning, & ExecutionValue added services that apply across the product lifecycle 01Development & Operations02Quality, Regulatory, & Compliance03Commissioning, Qualification, & Validation04Strategy, Planning, & Execution Supporting You Through Every Stage of Development At Kymanox, our solutions are rigorous, our support is endless, and our work is meticulous. Work With Kymanox Early Development From pilot studies or preclinical studies to Phase IIb, Kymanox provides many services helpful for programs in the early stages of development such as...-Human Factors Strategy-Project Management-IND Authoring & Submission Late Stage Development Phase III clincial studies and other later stage development activities can benefit from our technical and compliance solutions including...-PAI Readiness Planning-Scale Up and Tech Transfer-Control Strategy Commercialization Drug, device, and combination products submission services such as NDA, BLA, PMA, 505(b)(2), 510(k), DMF, and MAF including...-Submission Authoring & Review-Launch Preparation-QMS Upgrades & eQMS Post-Market Post-marketing surveillance (PMS) and life cycle management activities including Phase IV trials benefit from our expertise in areas such as...-Complaint Management & Investigations-Inspection Remediation-Process Verification (CPV) & Surveillance Markets That Benefit from Our Solutions Combination ProductsOur experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.Biologics and Cell & Gene Therapy ServicesWe understand why “the product is the process” and how to implement solutions to your unique challenges.PharmaceuticalsDrug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance. OtherOur diverse experience across the life science industry, including medical device and vaccines, ensures your challenges are in expert hands. More Than Consulting, an Integral Part of Your Team “Right First Time” Execution Get results with our branded methodology, Ideal Knowledge TransferTM Dynamic Project Management A personalized approach that combines your needs with our proven tools Flexibility & Agility Clients tell us our flexibility is a key reason they keep coming back Proven Broad Expertise Extensive experience across drug, device, & combo product development Kymanox CaresGiving back in a way that reflects our commitment to enhancing livesDiscover More Kymanox CareersJoin Kymanox to accelerate your career by helping our clients Get More DoneSee Positions Read the latest at Kymanox Analytical Techniques For Addressing Viral Vector Purification ChallengesWhen producing gene therapies, circular plasmids containing therapeutic DNA , an outer capsid shell, and proteins required for virus assembly are inserted into host cells. Manufacturers often face difficulties creating consistency in gene therapy produ... Rapid Microbiologic Methods Aid In The “Race To Release” Challenges Of Cell And Gene Therapy ManufacturingRapid Microbiologic Methods (RMM) is perfectly suited to cell-based manufacturing because it allows scientists to obtain results up to ten times faster than traditional culture-based microbiological analysis techniques and with less produ... Will The Real Critical Tasks Please Stand Up: How To Develop Your Human Factors Risk Assessment And Evaluate Critical TasksHuman Factors Engineering (HFE) is a risk-based discipline crucial to validating that a medical product and its user interface is safe and effective for the intended users and use environments. The HFE process aims to optimize the user interface for me... See More Blogs Stay Connected with Industry Trends & Insights Get In Touch +1 919 246 4896 [email protected] Our Locations Privacy Policy ©Copyright 2022 Kymanox Corporation