Products and Services

From biosimilars to NCEs and novel formulations for ethical chemical and botanical drugs, we have a wide variety of choices. Many more are coming and we would like to hear of your specific interests. Other services also available.

 

We wrote the book on biosimilars. We took many to market.

We wrote the book on biosimilars. We took many to market.

biosimilars

With over $200B market for biosimilars by 2020, no marketer can be without biosimilars. The traditional model will take over $200 million an 5 years for each product with high uncertainty. To achieve the goal of "fast to market," we develop biosimilars ready for licensing, ready to get into mainstream testing and approval. Our licensing model is just as innovative as our choice of products. The licensing package includes scaled-up technology, a written concurrence from FDA on clinical development, time and cost projections, and commercial supply if desired. You come in the picture when all uncertainties are gone. You know exactly what would it take to get approval. We provide you commercial supply, if you prefer, removing any need for large capital investment upfront. And if you are not a manufacturer, opens a business opportunity that you were not likely to have. The following products with $33B+ market are offered now; many more are coming soon. {current US market}

available now

Bevacizumab (Avastin®), Oncology, (Colorectal Cancer), $7B

Insulin Glargine (Lantas®),Type-1 and -2 Diabetes, $7B

Available in 6 months

Darbepoetin alfa (Aranasep®), Anemia due to CKD, $2B

Insulin Aspart (NovoLog®),Type-1 and -2 Diabetes, $3.2

Erythropoietin (Epoetin® ), Anemia, $3B

available in 2018

Liraglutide (Victoza®), Type-2 Diabetes, $3B

Trastuzumab (Herceptin®) Oncology (Breast Cancer), $7B


351k development begins starts with a robust Freedom TO Operate......

Licensed to practice patent law and with a proven record of innovations in bioprocessing and taking products through 351k filings, we have created FTO opinions for many biosimilars that can be customized for your process or created for your unique product. The legal battles are just beginning to sprout--don't make a mistake of starting without first understanding. Click here to see latest news.


FDA now has guidance on approval of botanical drugs (2016), a remarkable business opportunity

FDA now has guidance on approval of botanical drugs (2016), a remarkable business opportunity

alternative medicines

Now that FDA is open to approving botanical drugs, here is an opportunity of bringing to forefront safe and proven remedies thousands of year in use to patients in need. We have a long list of patented and proprietary products and hands-on experience o developing a regulatory dossier.


Our own patented NCEs, applications and formulations as well as dozens of represented entities that we had patented.

Our own patented NCEs, applications and formulations as well as dozens of represented entities that we had patented.

Ethical Medicines and formulations

From NCEs to combination drugs and novel drug delivery systems, we represent dozens of new entries. The development of NCEs is an expensive exercise, getting more expensive, the 505(b)(2) route is what we specialize in. Better response, greater safety, wider applications is something we have demonstrated for a variety of large volume drugs. We also represent the inventions we have successfully prosecuted.

Our best product is our understanding of science..