You must make sure your pipeline drug is protected upon approval by the FDA. No other application can be accepted by the FDA for the same active ingredient. Numerous legislations have been enacted to protect manufacturer rights depending on the patient demographics, diseases states and class of drug (Rx versus OTC). 

Many pharmaceutical companies have decided to hold immuno-oncology/rare disease medications in their portfolio and shed medications for chronic disease states. Ask our consultants how you can position your drug portfolio with market access in mind.

How do you go from drug development to FDA approval with success in mind? Please ask our consultants for guidance with these large projects. We will guide you every step of the way.

Whether it’s opioid litigation or generic manufacturers trying to copy brand medications, we will provide you all the legal insights within the industry at your fingertips.

How are you planning for loss-of-exclusivity? Will you manufacture a generic version of your own brand? Believe it or not, many manufacturers use the same plants to produce generics of their own brand name drugs. 

Market Access thinking starts from clinical development. Health Plans and manufacturers should discuss the right direction for reimbursement prior to FDA approval. 

• Medical Benefits
• Pharmacy Benefits

We can perform Market Research with Thought Leaders/Key Opinion Leaders (KOLs) at our disposal. Whether it’s in-person advisory boards or telephonic consultations, these insights can be gathered for manufacturers while providing an honorarium for stakeholders.

We can provide Doctorate-level scientific insights for on and off-label indications for medications. We will provide scientifically balanced information to end users including health systems, providers and pharmacists. 

We can eloquently write and publish pharmaceutical content in journals, websites and newsletters at your own discretion.

From development, it is wise to forecast revenue for a pipeline drug prior to FDA approval. We can utilize our pharmaceutical and business insights to create models for revenue prior to investing years and multi-million dollar budget on failed medications.

Market Access is one of the barriers for a post-market commercial strategy. Whether it’s a competitor that has a larger market share or has preferential tier on some of the largest health plans, we are here to help you grow.

We are here to evaluate your product for safety, efficacy, and tolerability prior to FDA approval.

How do you track success after launch? Your level of preparation will dictate your level of success. Have you sold the disease prior to launching the drug? Have you informed organizations about this launch? How does the landscape look prior to the launch?

Now, more than ever, have supply chain considerations been of profound importance to the industry. Medications like CAR-T cell therapies and vaccines requiring cold-chain temperature monitoring. With the dominance of the overseas markets and generic manufacturing; how will this impact the supply chain to the US? Talk to our consultants for more