Recent reports have suggested that an estimated 90% of Americans are using over-the-counter (OTC) medications to treat themselves before deciding to visit a doctor. The Covid-19 pandemic and the accessibility of health services online have all contributed towards more and more patients seeking treatment online. So this is a trend that is here to stay and the market for OTC products will continue to boom in the future.
With the OTC medications likely to increase in popularity, it becomes imperative to focus on the OTC component of your pharmaceutical company. LST consulting helps you take advantage of this situation by adopting smarter OTC product strategies. We help you adopt real and actionable steps to boost your business.
We help our clients find ways to meet targets within their budgets and decide if there is a need for the next potential OTC product. We help our clients decide the amount of time and money worth investing in research, development, and marketing based on consumer demand in the market. We also offer professional insight into ways to increase the efficiency of client's business operations and meeting deadlines.
An important point about OTC drug products is that these drugs do not require a medical prescription and are safe and effective for use. However, ensuring the drug you want to market is approved is not an easy process as the FDA constantly reviews the active ingredients and labeling of all OTC drug products.
This is where LST consulting steps in to assist you with the approval process. With more than 300,000 OTC drug products marketed across the U.S. region, the FDA carries out a regulatory review of these products. We understand that this review is not undertaken by evaluating individual drug formulations. With a thorough understanding of this review process, we help you navigate through the dynamics of this review smoothly and efficiently.
We help companies market a new product by submitting an NDA (505) (b) (1) or 505(b) (2) application. Though complying with the FDA requirements is a long and complicated process in the majority of the cases, we take care of all the hectic tasks in this process. We take care of the entire workload by adopting all the necessary steps from submission to compliance to the filing.
LST adopts two regulatory pathways as sanctioned in the U.S. under law. It may either be the OTC monograph process or the New Drug Application (NDA) process. In cases where the conditions of the legal requirements are not being met under the OTC drug monograph, then the process of NDA is undertaken to obtain approval.
The truth is that the regulatory oversight to obtaining an Over the Counter Medicine approval is challenging. Most companies find it difficult to navigate and challenging to fulfill. However, regardless of the hectic task, overcoming these regulatory burdens are well worth the effort if you view the return on investment you make.
Companies looking forward to approval need not stress over this complicated process as LST consulting provides all the necessary services required to win approval in the market. We also assist our clients in making an entry to the market and at the same time ensure a compliant and competitive position in the market.
LST Consulting provides a range of FDA regulatory services to the OTC pharmaceutical industry. Our services are a combination of a seamless approach merged with a focus on navigating the regulatory intricacies that organizations need to pass through in the domains of product development, submissions, claims, and labeling.
LST consulting also helps its clients in the manufacturing and packaging of commercial products while also tending to the tasks of facility and product registrations and listings. We are equipped with a team of regulatory experts who have vast experience in providing assistance that will help your organization transition to success in the market. Our efforts are focused on helping your company rise to the top despite the highly complex and competitive regulatory environment in the market.
LST Consulting provides a comprehensive range of services related to OTC Medicine and OTC drugs. We take care of all your needs starting right from drug classification. The necessary assistance in labeling is also provided to boost efforts to get your product approved. All the necessary OTC drug monograph applications are performed by us. In case your company requires any prescription to OTC switch applications, then we have you covered in this domain too.
In the case of the OTC Drug Monograph amendment, we undertake the preparation of the Time and Extent Application (TEA) to save you from this complicated hassle. Our tasks do not end here but we go a step ahead to assist you with meeting post-approval requirements too.
Our professionals are always available to collaborate with you through all the phases of the processes that need to be performed for winning the Over the Counter Medicine approval. Being adept and experienced with the FDA’s rules and regulations, we know which regulatory strategies need to be adopted to manage prompt and quick FDA compliance in all the stages of the approval process.
Equipped with an in-depth understanding of FDA regulations, LST consulting is in the prime position of determining and deciding the appropriate drug classification process, whether it is monograph or NDA to win approval. Additionally, we also assist our clients in preparing compliant labels according to the rules laid down in the OTC drug monograph. Even better for our clients, LST consulting provides its consulting services at cost-effective rates. With LST consulting, the drug approval process proceeds at a faster pace.
LST consulting is a life science and regulatory consulting firm with extensive experience in helping pharmaceutical, biopharmaceutical, and medical devices companies comply with the FDA regulations. We also assist with the strategic development of drug products and medical devices along with combination products. We also deliver FDA OTC drugs consulting services which include but are not limited to ANDAs, INDs, and NDAs.
Contact us today if you want your products to be marketed legally and appropriately as per the guidelines laid down by the FDA. Let us help you in adopting the best regulatory pathways by drawing on the experience of experts in this field. Our hallmark is helping our clients with their prescription/OTC strategies and drug combinations, which also includes meetings with FDA.
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