Listing ID #6946891
Company Information
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To enhance productivity and to optimise the operational cost, medicinal product manufacturers propose certain changes to the registered content of the medicinal product applications/dossiers. Any change to the registered content of medicinal products should be submitted to the respective Health Authority (HA) in the appropriate submission procedure with supporting data prior to its implementation. Based on the impact of the change, the requirement of prior approval would be determined referring to the CMC post-approval Regulatory affairs submissions (post-approval supplements/amendments/CMC variations) guidelines of the respective HAs. In this phase, the importance of the Regulatory strategy for post-approval Regulatory affairs changes submission is significant.
Avighnakalp Solutions (OPC) Pvt. Ltd. is one of the emerging, global, Regulatory-focused solutions and services companies for the Life Sciences industry. The company’s services include from pre-approval/Legacy Product Maintenance, Labeling, Artwork Change, and Submissions, as well as their entire Regulatory value-chain. From decentralized clinical trials to regulatory consulting services and leveraging real-world insights, our therapeutic, technical, and functional ability is underpinned by a patient-first culture embedded in our DNA. Our employees have a deep conviction in what we do, and together with our customers, we are shaping the next generation of therapies, one patient at a time. What we do, we do
We are leading provider of artwork services & solutions for global life sciences industry – Pharmaceuticals, Medical Devices, Cosmetics, and Consumer Healthcare…
Our Scientific and Medical writing team has proven expertise in delivering world-class Regulatory and Medical Writing services for its growing clientele of Pharma, other Biotech companies…
Our RIM is an end-to-end electronic Regulatory Document Management solution exclusively designed to enable Regulatory Groups and Departments within a life sciences organization to seamlessly create, capture, manage, organize, connect, deliver and archive Regulatory data and documents in a compliant, efficient and intuitive manner.
Our Approach
Each of us, no matter what we do at Avighnakalp Solutions, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.
Quality
From the smallest detail to the largest, we take quality seriously. We focus in on the detail while never losing sight of the big picture to drive the best possible outcome.
Empowerment
We recognize and uphold the importance of all people, the way we do things, our quest for innovation and most importantly, our patients. We follow our hearts; we do the right thing, and we have the courage to own the outcome.
Nature of Business
Service Provider
Number of Employees
Below 20
Year of Establishment
2022
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