Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

Not exactly...

No press release = Not that important = No follow-up questions.

In case one is unfamiliar with the role and responsibilities of a head of regulatory affairs, it is worth noting in pharma that Regulatory Affairs is a unique mixture of science and management that serves to achieve a commercially important goal within the drug-development function of a pharma firm. Regulatory Affairs manages the product development plan that includes supervising-writing / reviewing, assembling and submission. A VP of RA will give strategic and technical advice to the CEO and BOD from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole.

In today’s competitive environment, the reduction of time taken to reach the market is vital to a product’s and the company’s success. For a pharma firm, the proper conduct of its Regulatory Affairs activities is therefore of considerable economic significance for the company. Inadequate reporting of data may prevent a timely positive evaluation by the FDA of a marketing application. A good Regulatory Affairs professional will have a ‘get it right the first time’ approach and will play a very important part in coordinating the scientific endeavor with regulatory demands throughout the life of the product, helping to maximize the cost-effective use of the company’s resources. No small issue for a generic drug company like Elite that operates on a cost containment strategy.

Moreover, the Regulatory Affairs department is very often the first point of contact between the government authorities and the company. It is Regulatory Affairs that touches all aspects of a drug development – from assessing the quality of the API, to evaluating R&D , to engaging in quality control and assurance, oversight of manufacturing, to approving the proper packaging of the drugs. RA is responsible for compiling the dossier that includes all scientific data that is sent to the FDA that will be the basis for that agency (or any other regulator on a global basis) to assess the data for approving any drug. RA also maintains the necessary records to be used in any legal questions that might arise related to the specific drug.

While it appears that the VP of Regulatory Affairs will under Jason Lepree’s oversight, as its role is involved in the complete life-cycle of Elite's pharma products, to have someone specifically involved in RA is a BFD appointment. This is all about the level of business maturity necessary to get Elite to its next steps.

Hey AMA, you are welcome. Always glad to provide important learning points. It's why I am here...