TITENARE GXL Competitors

We thrive to provide focused, quality and flexible services to the utmost satisfaction of our clients building a long-term relationship.Success and strength of any company rest on its strong beliefs and values. We believe in customer service excellence, uncompromising quality, ethics and integrity, continuous improvement, and promotion of teamwork.The increasingly complex requirements of health authorities, coupled with a need to remain abreast of the rapidly evolving global regulatory landscape, demand for a dedicated team of consultants focused firmly on the pharmaceutical regulatory affairs sector.We provide sustainable outsourcing of all regulatory affairs services, which any pharmaceutical organization requires to sharpen their competitive edge and become successful in this era of cut-throat competition. With an elite expertise, we specialize in regulatory filings across all major markets around the globe for all types of products (Drugs, Biologics, Vaccines, Medical Devices, Cosmetics, Food and Nutraceuticals). Whatever your needs, simple market intelligence, agency regulations, submission assistance, or more complex expertise such as working with the regulatory agencies and management of post-approval activities, we can resource any regulatory affairs project. Our expertise has been crafted by handling market authorizations for many years in the continually evolving pharmaceutical industry of all major Health Authorities, with specific experts firmly focused on handling the Regulatory Consulting services [Regulatory Strategy, Regulatory Operations – CMC, Regulatory Intelligence], Regulatory Labeling, SPL, Graphics & Artwork Management, Electronic Publishing & Submission Management and Medical Writing & Pharmacovigilance services.As industry standards emerge, we continue to evolve our offerings and lead in the definition and execution of new business models for the pharmaceutical industry.For more info, please contact us at:contact@aariya.net

Pharmaceutical Development Group (PDG) assists firms in the navigation of the U.S. FDA submission, approval and post-marketing procedures across a variety of dosage forms and therapeutic areas. Our expertise spans prescription and nonprescription (OTC) drugs, both NDA and monograph, as well as devices and supplements.PDG possesses the resources and experience to address large scale development projects, long-term regulatory strategies and complex non-clinical and clinical issues. We can quickly and efficiently address unexpected emergencies and often faster than large companies can perform in-house. PDG maintains a posture of readiness to react and respond to your regulatory needs 24 hours a day, 7 days a week. We recognize that you may receive an FDA Form 483 or Warning Letter, may be faced with the possibility of a recall, or have encountered some other sudden and urgent situation. Regardless of the emergency, as your FDA regulatory consultant, PDG is always ready to respond without delay.We focus our experiences and energies to serve as your long-term regulatory partner throughout product lifecycles. PDG will develop strategic plans and lifecycle management options designed to maximize the safety, efficacy, and commercial value of your products.PDG’s clients span the globe and count on us for rapid availability and accessibility. Our team is always prepared to travel to your facilities, FDA, CROs, CMOs, or wherever the need arises. Join other successful companies who have chosen PDG to serve as a long-term partner in the maximization of the value of their drug products.

Katalyst Healthcares & Life Sciences Inc., is provides seamless, transparent and current good regulatory consulting services to clients across Pharmaceutical, Biotechnology, and API manufacture, Finished Formulations Manufacture, Medical Device, Food and Beverage companies. Our services range from a simple advisory service consulting to full IND, NDA and IDE preparation and submission, including submissions in electronic Common Technical Document (eCTD) format using cGXP systems. Highly experienced and broad knowledge Katalyst's team members, including Clinical, Medical Safety, Data Management, Statistics and Project Management, are available to assist as single or as a completely manageable fully functional clinical development team to ensure successful product registration in American, European and all other global markets. Katalyst HLS offers wide range of Regulatory Services: Regulatory affairs: CMC, Dossiers Regulatory Strategy and Intelligence from Molecule to Market. Regulatory Submissions: IND, NDA, ANDA, BLA and CTA applications (Paper & eCTD) Regulatory Writing: Clinical and CMC Regulatory support for Clinical Trials Regulatory Operations: Clinical and Non-Clinical Publishing and Submission. Regulatory Labelling: Clinical and Non-Clinical Regulatory Agency Liaising Regulatory Business and Outsourcing Consultancy