In today‘s competitive environment the reduction of the time taken to reach the market is critical to a product‘s and hence the company‘s success. The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the company. Inadequate reporting of data may prevent a timely positive evaluation of marketing application. Even worse1 failures to fully report all the available data or the release of product bearing incorrect labeling, may easily result in the need for a product recall. Either occurrence may lead to the loss of several millions of units of sales, not to mention the resulting reduction in confidence of the investors, health professionals and patients. A good Regulatory Affairs professional will have a ‗right first time‘ approach and will play a very important part in coordinating scientific endeavor with regulatory demands throughout the life of the product, helping to maximize the cost-effective use of the company‘s resources. The attitudes and actions of the Regulatory Affairs professionals will condition the perceptions of the government officials to the company for better, or worse Officials respond much better to a company whose representatives are scientifically accurate and knowledgeable than to one in which these qualities are absent. The importance of the Regulatory Affairs function is such that senior Regulatory Affairs professionals are increasingly being appointed to boardroom positions, where they can advise upon and further influence the strategic decisions of their companies.

Keywords: Regulatory Actions, Misbranding, Adultration.

An oral dosage form faces a number of challenges concerned with Pharmacodynamic and Pharmacokinectic characteristics responsible for producing a desirable results in obtaining the optimal efficacy. Such challenges may be of wider to narrower magnitudes. An innovative approach to solve such problems focuses onto the enhancement of certain parameters i.e. disintegration and dissolution time, absorption from specific parts of GIT, bioavaibility of active medicament present in the dosage form, onset & duration of action, etc. It must accompanying reduction of toxic effects of variable nature. The present work was aimed at development of Elementary osmotic pump dose formulation (tablets) of Iminostilbene anticonvlsant drug (the name kept secret due to the ongoing patenting process) abbreviated as DABC. EOP dose formulation has been reported in literature to be effective in oral therapy with optimized Pharmacodynamic & Pharmacokinectic properties together with reduced toxic parameters. Solid dispersions of the drug were prepared using polymers i.e. PEG 6000 and Plasdone S-630. The dispersion with PEG 6000 was prepared by fusion method while with Plasdone S- 630 it was prepared by hot melt hot granulation. The dissolution studies were carried out with different formulation batches and the optimized formulation was selected for future studies i.e. the drug:PEG 6000(1:2) and drug:Plasdone S-630 in the same ratio. The latter also contained 33.33% of PEG 6000 as a plasticizer. The core tablets were formulated with the optimized batches. The comparative dissolution studies of these two batches carried out with produced core tablets in water revealed that former as solitarily optimized batch. Now the finally selected batch of tablets were seal coated (with 3% HPMCe5cps). Functional coating was done with the entire batch using 3% Cellulose acetate. Keywords: Iminostilbene, Osmotic Pump, Development.

Buccal delivery administers drug through buccal mucosal membrane that is the lining of oral cavity. The drug reaches
systemic circulation by internal jugular vein and drugs bypass through hepatic first pass metabolism which shows higher
bioavailability. Cetirizine hydrochloride is Histamine antagonist that is commonly used to treat throat inflammations and
irritation. The patient usually feels discomfort while administering the drug and so the buccal delivery is the best suited route of
administration and the oral absorption is usually preferred in this respect. In this study a mucoadhesive formulation was prepared
using mucoadhesive polymers and were investigated for the formulation parameters

The modified mythology is used to plan different drug delivery systems in order to achieve controlled release drugs are used for
topical application along with carrier system from the past few years. The micro sponge is used to modify drug delivery system
consisting of patent, porous, polymeric microspheres to protect the active ingredients of drugs. While non- conventional dosage
forms such as non hydrophillic ointments having short resistance on the skin. Now a days, Cosmetics, sunscreens, OTC skin care
products, prescription products are prepared by this micro sponge method the preparation of Piper extract microsponges as it is a
rapid, easy, consistent method and has an advantage of nullifying solvent toxicity. It was observed that as drug: polymer ratio
increased, particle size decreased. This is likely due to the fact that at higher relative drug content, the amount of polymer
available per microsponge to encapsulate the drug becomes less, thus reducing the thickness of the polymer wall and hence,
smaller microsponges.