API and Fine Chemical Manufacturing

API insight from custom synthesis through generics

In order to succeed, you must be able to fill your facilities with profitable projects that match your capabilities and ambitions

This requires a disciplined product strategy for both pipeline synthesis and commercial scale manufacturing. We can help you to adjust and optimize your portfolio over time to successfully address market and competitive changes.

Assess new compounds entering clinical development for compatibility with your company’s capabilities

In order to identify, win and execute interesting new custom synthesis projects ahead of the competition, you must be able to evaluate the commercial potential of new compounds entering early clinical development.

Anticipate and track the world of new drug research and development to understand the synthesis of new compounds and patent linkage, and the opportunities they may present for your business.

 

Identify and evaluate the most promising generic product opportunities to grow the business

Knowing when generic manufacturers will target launches in all your target markets is the key to anticipating your prospective customers’ needs before they do.

Identify future generic products that match your abilities and goals with unique, primary intelligence including competitive landscape, product volumes, available routes of synthesis and potential customers. Quickly evaluate when generic launches are possible in your target markets, and which competitors are already working on those generic APIs.

 

Monitor international regulations to assure compliance

With global regulatory, cGMP, and inspection regimes tightening, supply chain security is now a “must have” for buyers in many lucrative markets, and user fees now make market entry a costly decision. Understanding and anticipating global shifts in regulations and their impact on you, your customers, and your competitors is paramount.

Track regulatory changes, compare competitive products and prepare for meetings
and inspections. As you grow, easily understand the latest regulations in your target markets and what paperwork you must file by leveraging expert data on regulations in more than 80 countries.

 

Confidently assess your Freedom to Operate, prior art, and protect your own IP

To be competitive, you need to fully understand your freedom to operate, whether determined by the innovator’s patents or those of your competing API producers.

Understand the global patent landscape for a pipeline or marketed compound and your freedom to operate and infringement risk, as well as what opportunities might be available to generate new IP either for your own company or on behalf of a partner.

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