Regulatory Affairs

Regulatory Excellence at Nucare Laboratories

Regulatory Affairs is a highly competent team with strategic and tactical experience that manages the modern regulatory landscape by following regulatory practice, monitoring changing legislations and designing appropriate regulatory strategy and guidance for development and manufacture of products. It specializes in understanding the path ways and requirements of various regulatory authorities to work in collaboration with respective departments to generate first-time documentation for faster approvals and early launch of the products to create opportunities in a regulated environment.

NuCare Provides complete regulatory affairs support to its partners. The in-house team of pharmacists and packaging-development experts ensures correct compliance with the regulatory requirements of all countries. The regulatory team prides itself on sending complete & error-free dossiers every time and give quick, relevant and satisfactory explanation of any query in an a professional manner. In-fact, NuCare has a dossier bank for dossiers for immediate submission to various countries.

SOME OF OUR EFFORT TO

promote ethical behavior include

Customized Manufacturing

Medwise team can provide you the customized manufacturing of products on the client choice of brand name and packaging in terms of attractive designs and quality material along with sufficing regulatory requirements.

Product Marketing

Our team can provide the inputs and guidance on new product launch, formulation, dosing, packaging aspects, patented molecules suggestions (subject to patent law of country) as well as technical assistance in terms of marketing strategies and promotional literature.

Dossier Preparation

We have experienced team which is expert in preparing the dossier as per requirement of various regulatory authorities of respective countries in CTD, ACTD or any other customized format for product registration.

Technology Transfer

We are providing one stop solution for product development starting from API sourcing to technical requirement of equipment/machineries to formulation development from lab scale to commercial development to packaging along with on-site service as and when required.

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