Pharmaceutical Consultant – The Key To Doing Things Right
Launching any healthcare product is a serious and complex task. Every year hundreds of companies around the world submit their applications to obtain FDA approval. Around 60% of newly-launched drugs enter the American market before any other country, so the authorization obtained from this agency is vital. For most companies, this is the only safe way that their products can be commercialized anywhere in the world.. The most efficient way to get such approval is with the assistance of a good pharmaceutical consultant. FDA approval is extremely important for consumers of the new products, because FDA approval is the only way to be sure that the product will be completely harmless to both ones health and the environment.
The FDA has been responsible for assessing quality, innovation, and security in healthcare products since the late 1930’s. By 1927, its main role was that of analyzing and evaluating Food, Drugs, and Insecticides, but its responsibilities changed dramatically due to unexpected tragic events that took place in 1938. That year, more than 100 people died because of the consumption of a highly toxic tonic which had entered the market without any clinical trials. Sadly, but as a result of the tragedy and people’s protests, the Federal Food, Drug, and Cosmetic Act was soon passed, entitling the FDA to pre-approve all new medications introduced into the interstate market. Then, with higher responsibility and much more power, the FDA became the universal agent of quality control for medication and cosmetic products, and today its authorization is sought continuously by laboratories and related businesses, in order to be able to commercialize their products freely. Nowadays, the whole process of approval takes around 12 months but the product needs to undergo many testing and evaluation processes, apart from the strict control of all related points. The difficulty in obtaining the authorization lies in the fact that all products being launched to the market need to be safe and proper for human consumption and do not produce undesirable side effects. To comply with all the regulations, most companies seek the assistance of a pharmaceutical consultant to help them with the application process, clinical trials, quality control, document design, quality audits and in some cases, the best strategy to commercialize their products.
A pharmaceutical consultant is still the most effective way to assure FDA approval and maintain compliance with all the universal regulations that are related to the approval of new medications, vaccines, and other healthcare products. Pharmaceutical consultants are highly specialized professionals in the bioscience industry who are ready to give you multiple turn key solutions to refine your processes, test your products, and pave the way to the successful launch of your product into the market. A proper pharmaceutical consultant will not only give you support in the design of clinical trials, but will also be able to mock FDA and EU audits, conduct compliance assessments (GLP, GMP, GXP), give you QC/ Analytical support, Medical Device support, GMP training, Document design and preparation, and help you in the development of quality systems, for example. Their role is to guide you through technical and regulatory hurdles associated with FDA licensure or approval and commercialization of your product.
Depending on your needs, a pharmaceutical consultant will provide you with multiple solutions and offer different ways to staff your projects, always seeking the most cost-effective and timely manner to lead you to success. Make the process of FDA approval easier rather than a daunting process. From large multi-team assignments to 1 to 2 consultants’ assignments, pharmaceutical consulting companies possess a critical mass of resources to provide you with the best alternatives to both, obtain FDA approval and get the competitive edge to become a market leader in health care products. They will adapt to you and work in your projects as team leaders, substitute staff or temporary staff members, but always stay focused on the best results. You provide the ideas and the product. They provide their expertise.
From the moment your new healthcare product is born until the moment it enters the market, a good pharmaceutical consultant will be there to guide you through, all the hurdles. Starting from regulatory submissions and preparation to technology transfer, or from business plan preparation to competitive analysis, you will find in your pharmaceutical consultant an invaluable tool to transform your innovative ideas in healthcare into pure success. It’s a fact. The perfect combination between science and business, pharmaceutical consultants know how to help your product reach the market and be the solution to an unmet medical need. Let your contribution to a better and healthier world come true by allowing us to provide an enhanced level of certainty in the FDA regulatory process.