GENERICS, OTC AND DRUG DEVELOPMENT SERVICES
We provide flexible licensing opportunities and pharmaceutical solutions
enabling our customers to accelerate their products, route-to-market
quickly, safely and cost effectively.
We develop our own formulations which are made available to our customers,
accompanied by technical documentation for product registration
or application supporting.
Also we will develop new formulations or we modify existing ones in close
cooperation with the customer, to realize and guarantee increased product
safety and stability.
ANALYTICAL SUPPORT AND DEVELOPMENT
We developed a strategic alliance with CHELAB Laboratories, one of the
biggest analytical cGMP authorized site across Europe, to provide a wide
range of analytical solutions.
We offer the best services for development and validation of analytical methods, supplying analytical method transfer protocols, products validation
and stability study testing, using the most complete and modern
variety of chemical and microbiological techniques.
DOSAGE FORMS, DEVICES AND TECHNOLOGY
We can provide a variety of oral dosage forms to satisfy different market
requirements:
- effervescent tablets
- effervescent granules
- chewable tablets
- film coated tablets
- oral dispersable tablets
- soft gel capsules
CUSTOM MANUFACTURING
We work with contract manufacturers from every part of the world to give our customer the highest quality at the most competitive price. We can
satisfy small to large volume production.
Our formulation development can include a sampling service for many dosage forms. Validation and scale up of manufacturing processes complete
our experience and allow us to extend our manufacturing services
to customized packing and distribution. We offer global out licensing
opportunities in available countries.
ADDITIONAL QUALITY SERVICES
We also offer additional pharmaceutical services including regulatory
consulting and assistance, approval for labels, auditing, dossiers for generics
and documentation.
Technical dossiers for new registrations or for the renewal of registration
are prepared in e-CTD format.
These extended activities can be used individually or as part of a multiintegrated
project.