Comprehensive single-source provider from drug product development through commercial manufacture:
we offer a complete service including:
- regulatory strategy evaluation
- formulation development
- scale up
- manufacturing process validation
- analytical methods development and validation
- ICH stability test
- clinical development
- clinical operations
- eCTD preparation
- patent support
From design to finished product, we support our customer’s project all the way.
We apply the most recent technical-scientific methodologies in compliance with the international guidelines.
We are specialist in solid oral delivery forms, focusing on our technologies and dosage forms: effervescent, orally disintegrating, sublingual and soluble.
High level of outsourcing from dossier technical evaluation to private label manufacturing.
We produce your product under your brand at our certified manufacturing plant with high focus on quality, cost efficiency and on-time deliveries.
We proactively endorse in-technology transfer projects to manufacture existing commercial products. After a technical evaluation of the dossier, we offer a full activity plan including:
- manufacturing process transferability evaluation
- possible formula and manufacturing process optimization
- analytical methods transferability evaluation
- potential development and validation of new analytical methods
- stability study under stress conditions
- scale-up of the manufacturing process
- industrial batches manufacturing and validation with related documentation on support
- ICH stability plan
- Regulatory evaluation
- Regulatory documentation
- Commercial proposal with costs optimization
We grant GMP compliance, regulatory compliance, flexibility, production capability, and a full customer-oriented service.
We independently develop new pharmaceutical products on the basis of our technology platforms, delivery forms and know-how.
We bring forward our innovative projects from design up to the registration and marketing authorization of the drug product.
The Marketing Authorization and related registration dossier will be then ready to be transferred or licensed out to our partners worldwide.
We out-license our registration dossiers, fully developed in house, for the partners to register and apply for a Marketing Authorisation in their country/-ies with their own trademark.
We are also willing to follow the registration procedure up to the granting of the Marketing Authorisation on behalf of our partner (in Europe) and then transfer the related MA once obtained directly to our partner.
In both cases, the partner becomes the MA holder and E-Pharma the finished product manufacturer.
We grant professional regulatory support from pre-approval to post-approval stage for the full lifecycle of the product.