Products and services tailored to OTC product development.
Over-the-counter (OTC) medicines are drugs often bought off the shelf that do not require a doctor's prescription. In most cases, OTC medicines are well-established medicines with recognized efficacy and an acceptable level of safety, which have been on the market for 10 years or more.
Although non-prescription, OTC medicines are still regulated by the respective regional governing bodies. In the U.S., OTC medications are regulated by the FDA through the OTC Drug monographs.* In EMEA, non-prescription drugs must be registered by the European Medicines Agency (EMA) or other national agencies.
*OTC drug monographs are a listing of acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not must undergo separate review and approval through the "New Drug Approval System."
The OTC market is projected to grow at a CAGR of 5% by 2024 – [Contract Pharma, February 2018]. This rapid growth is fueled by an increasing number of consumers who want a fast-acting and affordable remedy.
Today's patients are increasingly managing many of their ailments through the selection of OTCs without consulting either a doctor or pharmacist. This practice is commonly referred to as ‘self-medication or self-care.’ Consumers are looking for safe, effective and affordable OTC drugs as they become increasingly involved with self-care to meet their needs.
However, as a mostly consumer-driven market, it needs increasingly higher product differentiation to help achieve product success and sustainable life cycles.
A highly competitive marketplace requires brands to innovate continuously and offer new line extensions with the presentations of existing products. We work with our customers to help end consumers achieve happiness with the options available to them. We can help distinguish your brand from other products on the market with similar therapeutic advantages.
Our expert, cross-functional teams of sales, marketing and formulation development colleagues work closely with our customers to develop exclusive products based on original insights into the latest consumer and market trends of the pharmaceutical industry.
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