At Naxpar, we understand that often companies, especially those not based in India, require assistance with breaking through the regulatory framework and establishing their presence in the sector. For this purpose, we offer a number of important services, these include, but are not
• Identifying the Drug/Product
Often, organizations are able to identify the specific therapy segment they are keen to enter, but unable to find a viable product opportunity. In these cases, Naxpar has both the knowledge base and the skill set to help. Our development team works together with the Formulation department to use a detailed briefing from the customer’s end to find an end-to-end solution.
• Developing the Drug/Product
Once the drug/product has been identified, Naxpar provides companies with the service of stabilizing the formulation, right from pilot scale to commercial production.
• Gaining Regulatory Approval – Product Dossier Preparation for Drug Registration (Common Technical Document
The FDA process can be a cumbersome one, especially for those who lack experience in the area. We will assist you in the preparation of the relevant
dossiers, both CTD and non-CTD formats. These will be made as per the requirements of the Ministry of Health/FDA of the respective country. At Naxpar, we are keen to leverage our collective experience for your benefit.
In-licensing arrangements with Naxpar will enable companies to explore robust marketing opportunities. By leveraging our already existing expansive distribution network, niche and innovative products will benefit most, especially those which have boast an efficacy or cure to a specific ailment.
At Naxpar, we have a number of niche products. These have been established in India and now, we are keen on exploring distribution opportunities across the globe. To achieve this, we would be willing to ensure exclusivity to the said collaborator for marketing rights of the decided product in that country.
• NDDS Tie Ups
With New Drug Delivery Systems (NDDS) making waves in the global Pharmaceutical landscape, it has become important, now more than ever, that Pharma companies ensure that there drug delivery mechanisms are constantly updated. Naxpar offers key services in this regard, do reach out to us for additional details.
• Manufacturing Tie Ups and C.R.A.M.S
Naxpar provides companies with the service of developing the drug through Contract Research and Manufacturing Services (C.R.A.M.S) or manufacturing collaborations. Having developed substantial expertise in the manufacturing and research space, with 3 accredited facilities, Naxpar is well placed to
provide this assistance.