Press Release:

Today Smart Consulting Group LLC of West Chester Pennsylvania announces that on Wednesday 22 July it was awarded a GSA contract on the MOBIS schedule to provide business consulting services to the US government. The focus of the award will be to provide services in the Life Sciences Sector to support the work of the various agencies that support these activities. This could include departments like HHS and their respective agencies: FDA, CDC, NIH, NIAID & BARDA and the department of defense which might include CBRN engaged in medical countermeasures programs.

Speaking about the award, Nigel Smart a Managing partner with SCG said, “This is an exciting development for our company and further validates that we have become a significant credible supplier of Life Science Consulting Services.” “The award of this GSA means that we can now interact directly with government agencies that want to use our capabilities and this has to be a win win situation for both parties.”

Smart Consulting Group LLC is launching a major initiative to encourage teaming & partnering arrangements with other groups to expand & enhance the scope of the services it supplies to the government. Interested parties should contact the firm via its inquiries line at inquiries@smartconsultinggroup.com

Smart Consulting Group is looking for consultants of varied experience to work with clients teams to develop project plans, assist with policy development, prepare working proposals and to provide technical support to facilitate the development of new products.

Consultants should have a BS degree and preferably an advanced scientific degree with experience in biotechnology/pharmaceutical product development & manufacturing.

Experience in all scientific disciplines which support these activities are of interest including but not necessarily limited to: molecular biology, cell culture, fermentation, downstream processing, protein purification/purification, fill finish, manufacturing operations planning, supply chain, drug policy development & project/program management.
Smart Consulting Group is looking for enthusiastic, energetic highly motivated self starter professionals that have well-developed interpersonal skills and have a desire to contribute at the highest level of their professional capabilities to make a difference.
We require individuals that can work independently and as part of an integrated team & have a well-developed sense of personal time management.
Salary/compensation will be commensurate with industry competitive rates.

Location: the DC/Mid-Atlantic Region and remote travel locations.
Travel may be required for some assignments.

To send resumes/request additional information contact
inquiries@Smartconsultinggroup.com

Processability, stability, and uniformity of content are a few of the factors influenced by particle size of drug substances. To avoid undesirable effects, adequate analytical methods should be used. Once these methods and specifications have been set, variability in analyses and manufacturing should be also considered. Manufacturing processes determine the particle size characteristics, so it is a challenging task to control variability. The reproducibility of particle size analysis is also determined by manufacturing processes, so this subject is of great importance due to the order of magnitude of variability in particle size as determined by processes instead of, for instance, analyses for purity.

It is interesting to look at typical manufacturing and analytical variability and how they affect the results of laser diffraction analyses. Milling, quality of unmilled product, different instrument vendors, homogeneity, reference materials – are all examples of factors that can account for variability. By some estimates, the deviations of the characteristic values of the particle size distributions were in the 20% range. Due to this, it is evident that quality cannot be guaranteed within a smaller range than that given by the compound variability of these factors.

These points all contributes to the challenge of publishing adequate specifications and specification documents that help assure the quality of pharmaceutical products, especially when it comes to particle size.

Pharmaceutical consultancy firms are often contracted to help sort out these problems due to their knowledge of several benchmarked and in-house testing methodologies and techniques, through their work with many firms in the pharmaceutical manufacturing industry.

Particle size is a very important factor both when talking about an intermediate product and a consumer-ready product.

Intimidating as they may seem, FDA pre-approval inspections are vital to obtain final approval from the FDA. You may be well aware that you are supposed to follow all FDA rules and regulations in your facility, but inspectors will still want to know if the whole process of developing a new product was performed under FDA standards and using current good manufacturing practices (cGMP).

This stage demands hard work and can’t be effectively completed without suitable preparation. A pharmaceutical consulting firm will usually advise you to extend these efforts for FDA pre-approval inspection preparation to  the whole production process and not just to facilitiy issues.

In consideration of this, some key steps that will help to facilitate the appropriate preparation which should lead to a favorable response might include the following:

1. A thorough understanding of the inspection process:
After analyzing all your application documents, the FDA will dispatch inspectors to check on the accuracy of the application from a compliance perspective.. They will be looking for problems, and if they can’t find them, it’s been known for them to turn  the premises upside down, to ensure that there are no show stopping compliance issues.
They expect you to have some issues (this is only normal), but their main concern is how you address such issues; Is there a plan and on over-riding philosophy and culture of Quality Compliance at the site.
If they gain the impression that your company is trying to control these problems and has a rationale plan for maintaining control then, they will interpret that  in terms of the site  as having a higher quality standard.

2. Preparing for the inspection:
You will receive plenty of advance notice from the agency, and this will give you adequate time to prepare your site for the inspection. This will include: conducting internal audits, educating your personnel about the inspection process, training people to deal with the inspectors (a list of Do’s and Don’ts will be much welcomed),and preparing a document room to provide key documents to the inspection team as requested.
A key part of this process is to make sure that people are appropriately prepared to answer questions about their responsibilitires so that they minimize the chances of making mistakes or saying the wrong things Which can lead to ambiguities.

3. Confirmatory evidence:
Generate documented evidence of compliance with FDA regulations; be familiar with all FDA guidance documents and manuals. Review warning letters, prior FDA 483’s, prior establishment inspection reports (EIR). Make a list and check all external and internal documents, watch especially if the in-house documents match the documents presented to the FDA.

4. Managing the inspection:
Prepare an inspection team with clear roles to deal with the inspection and FDA inspectors. Prepare two specific rooms to ease the inspection: an Audit Room where the inspectors can interview your personnel and a Staging room or back room, to keep all the documents at hand and process all of the inspectors’ requests. Conduct mock audits regularly to evaluate your compliance status and see how your personnel responds to questioning.

Even though the preparation of these pre-approval inspections demands a lot of time and effort, it is probably the safest way to approach the process. By systematically performing all of the activities mentioned above, it is possible to both remediate any issue arising from the production or application processes, and be ready to successfully address any incident and close the gaps, thus ensuring the highest quality standards and products.

The issue of the cost of pharmaceutical products has been questioned for quite some time, but the industry has been unable to deliver concrete answers. Why exactly are pharmaceuticals so expensive? In the late 1950s, the same was asked by Senator Estes Kefauver, who was the first to pass an indictment against some fraudulent practices by the pharmaceutical industry. Senator Kefauver saw some inconsistencies, which are still alive: prices are extraordinarily high and profit margins excessive; prices are increased by marketing expenditures; and new products are not always more effective than those already in the market.

One main problem is that, even back in the 50s and, of course, to this day, the marketing budget is a lot higher than what is spent on research and development (known as R & D). In the US, direct marketing is legal, so pharmaceutical companies can invest on direct to the customer publicity, which results in more sales and therefore more profit to the business. It is commonly held, however, that the reason why pharmaceutical products are so expensive is that millions are spent on research. This is true, but there is also a considerable amount of money spent on marketing trying to pursued customers to buy their products and this inflates the overall costs.

A recent study by the Public Library of Science demonstrated that, actually, companies spend double on marketing campaigns than on R & D for their products.

Moreover, in global terms, about 30 percent of the money spent on marketing is not accounted for in the companies’ figures and books. This means that even more is spent on that part of the commercial process associated with marketing  pharmaceutical products. In all, it is estimated that a total of  $57.5 billion was spent on marketing needs on 2004, while only $31.5 billion was spent on Research and Development.

A pharmaceutical company is crucial to the economic, social, and vital growth of a country. As a leading country in pharmaceutical production, the US should set the grounds on the ethical and moral implications this has on the rest of the world. Pharmaceutical consultants have the experience and knowledge to, among other areas, be able to advise companies on what the best course of action regarding budget and expenditure is. The industry now faces times of economic turmoil and, more than ever, needs to adapt to the new times ahead.