Fda compliance for pharmaceuticals regulatory planning fda clinical trials mdi consultants anxiety attack vs panic attack symptoms

Our FDA compliance service line enables you to get your products to market quickly and to maintain your FDA compliance status. mdi has helped hundreds of companies to achieve and maintain their FDA compliance. Below, you will see a list of our specific service offerings. Product lifecycle

Given that we understand the product development process, the FDA submission process and the interplay between these processes, we can craft a regulatory strategy based on your situation. hypoxic encephalopathy radiology This strategy will include thinking through what actions you take, what you document, what submission process to take, how to structure your clinical trial, etc. How can mdi assist you?

• Minimize the cost spent in the submission process by defining a specific roadmap that allows you to identify the correct type of submission, eliminate the typical clinical trial management mistakes and reduce quality system implementation errors


Our services include developing the clinical protocol, setting up and interacting with the IRB (Institutional Review Board), submitting the IDE (Investigational Device Exception), recruiting and working with the investigator, monitoring the trials, data gathering and analysis, project management, and statistical analysis. nanoxia deep silence 4 mini How can mdi assist you?

We work closely with the product’s sponsor in managing the clinical trials required for market approval. The study’s protocol would be based on the necessary requirements for obtaining FDA’s approval in the quickest and least expensive manner. NDA/NDA/DMF Submissions What are mdi’s ANDA/NDA/DMF Submission Services?

• An ANDA (Abbreviated New Drug Application) is a required application that must be sent to the FDA in order to market a product in the U.S. anoxia vs hypoxia An ANDA must be submitted for the generic version of the brand name drug providing the FDA how your generic version is similar to the brand name drug.

• A NDA (New Drug Application) is a required application that must be sent to the FDA in order to market a product in the U.S. A NDA is required for all new drug products (never sold in the US previously) that you want to market. The NDA application is required to provide the FDA all the pre-clinical and clinical data providing the safety and efficiency of the product as well as all the manufacturing processes.

• A DMF (Drug Master File) is a file that is submitted to the FDA that includes technical, clinical, and safety information about an API (Active Pharmaceutical Ingredient). If you are an API maker, your customers may desire a DMF from you. mdi guides clients through the entire application preparation and submission process.

Our staff has in-depth knowledge on how to submit these applications and has developed strong relationships with the FDA over the last 25 years. causes of test anxiety psychology Given our experience, we can work with you to successfully achieve approval for your submission whether you want us to do it completely or for us to simply guide you through the process. FDA Quality System Strategy What are mdi’s FDA Quality System Strategy Services?

• Assuring FDA compliance to quality system requirements is critical for all medical companies. The quality system requirements are defined by QSR (Quality System Regulations) /cGMP (Current Good Manufacturing Practices) guidelines which are specified by the FDA.

• The process by which to achieve compliance to these requirements is different for each company. For example, large companies may need to prioritize geographically-different operations based on size/importance and implement systems accordingly. anoxic brain damage icd 10 A smaller company may need to prioritize which elements of the quality system to implement first (e.g. work instructions, design control) in order to get in compliance quickly.

Making these types of decisions requires thought and planning because these decisions will affect the speed and cost of the total implementation, potential savings that could be realized through a quality system implementation and the level of comfort the FDA will have that you are implementing a compliant quality system. Quality System Implementation What are mdi’s Quality System Implementation Services?