Listing ID #6946879
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Contact SupplierRegulatory assessment/Gap analysis of the supporting documents/data is critical for the registration of medicinal products. Though most of the Health Authorities (HAs) accept applications/dossiers in the CTD format, the level of content to be provided in the CTD section vary from each other. Thus, a thorough gap analysis/technical assessment of the documents/data enables the manufacturers to identify and mitigate the gaps before Regulatory submission. It will avoid Regulatory rejections of the submissions and minimize any major/critical queries to fasten the approvals.
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.