A $15.8 billion dollar bidding war for Salix Pharmaceuticals just came to a dramatic end as Valeant Pharmaceuticals beat Endo International with an all-cash offer for the company. While some view this as game changing, the truth is that the pharmaceutical industry is beginning to see this as status quo. According to Thomson Reuters, 2015 has seen pharma deals reach $59.3 billion – a 94 percent increase over that same period a year ago – and the highest value for this stage in any year since 2009. By contrast, many best-selling products are losing their market exclusivity and advances in biotechnology, thereby undercutting the entire concept of a drug . As a result, the pharma industry is being pushed to fill product pipelines faster than R&D departments can develop new compounds for commercialization. A classic example of how the term “drug” has changed with time is illustrated by the crossroads that the industry is in right now. Previously, a drug was a small-molecule, chemically-manufactured product. However, today, large-molecule biologics are the real center of drug innovation, and medical devices are even competing with traditional drug therapies. According to recent economic trends, it may now cost an average of $2.5 billion to get a novel drug to market. Further, very few products ever hit blockbuster status – $1 billion in annual sales – making the investment for R&D increasingly costly for companies. It is therefore necessary for a company to have a vendor who knows the industry’s fluctuating wavelength and has the desired acumen to stay ahead of the game.
Based in the United Kingdom, ELC Group leverages its expertise in extending specialized services in areas like chemical and pharmaceutical, pre-clinical and clinical, pharmacovigilance, information prescription and supporting regulatory affairs to provide key services to its clients. The services offered range from advanced integrated technologies, regulatory affairs consulting to commercialization services. Adhering to a well-planned strategy that carefully scrutinizes all the developmental variables like IP analysis, development and registration costs, submission feasibility, choice of clinical trials, scientific advice and predicting probable outcomes of registration, ELC Group keeps in mind the diversity of the particular region. The company‘s thorough examination of these variables ensures that the clients bear minimal or no errors, thereby not only helping them to overcome the time-to-market challenges but also trimming down excess outages .

Successful Implementation of Solutions and Services via Prudent Partner Selection
Among the crowd of formulation developers, CMOs and CROs, it is laborious but equally imperative to select a suitable partner for each product that the company endeavors to develop. That is why ELC Group chooses its solution partners after delving deep and conducting a thorough examination of a potential solution partner’s abilities, expertise and procedure. The solution provider is usually chosen based on the service that ELC Group intends to offer and its regulatory implication, the CRO’s capabilities and past experiences, financial stability and a range of other factors that are crucial for the successful implementation of projects. The in-house Quality Assurance Cell ensures that the deliverables fit the bill in terms of standard quality norms. Combining this with ELC Group’s in-house Regulatory Management tools and databases, the company finds it quite easy to navigate effortlessly through the regulatory landscape. Such strategic partnerships have been crucial for the company to stay ahead of the game by being a one-stop solution provider. Furthermore, ELC Group proffers services such as scientific advice, formulation development, analytical method development, Clinical/ BA/BE studies, GMP and QP services, dossier compilation and publishing and life cycle management to name a few. With the company’s well established global offices in every region of the world, ELC Group armsitself with major insights from the regulatory agencies and the distinct needs of the people which ultimately give the company the extra boost. As a testimony to ELC Group’s smooth transition through the regulatory landscape, the company has been particularly successful in furnishing complicated products such as drug-device combination products, paediatric submissions and innovative health technology products.

Benefacting R&D with Models based on Mutual Success
With a constant watch over the Healthcare and Pharmaceutical ambit, ELC Group strives to provide strategies for product development and commercialization to achieve maximum impact. Leveraging its strong foothold in the regulatory framework, the company is working towards improving the market access of drugs that were previously unaffordable or unavailable in the markets.“Working with start-ups and established companies alike has helped us to sharpen our capabilities while ensuring that the patients benefit from effective and safe medicines at competitive prices,” says, Akhil Jain, President & COO, ELC Group. A fully integrated Life-Science service provider, ELC Group battles various challenges that scientists face during the transition from the concept to commercialization processes. ELC Group partners with scientists and understands their need and effectively manages their projects. Additionally, the company provides a choice for these scientists as they can chose to partner with the company depending on their need, as ELC Group takes up whole projects as well as short contracts for different stages. A few of the services that the company proffers to the scientists are IP valuation, Product Strategy, R&D, Regulatory Strategy, Product Registration and so on. While most Pharma services work on a fee-for-service model, ELC Group opts for a co-development model based on mutual success like performance-based contract, risk-sharing or win-win partnership models.

Spreading out its Services across all Healthcare Sectors
Unlike their peers in the industry who cater to a specific part of the formulation-to-market process, ELC Group segregates itself by providing end-to–end solutions at one-stop availability. Similarly, the company does not limit its solutions to Pharmaceutical products but stretches out to medical devices, biologics and small molecules, vaccines and chemicals. Recently, the company welcomed a project worth 1m$ which is being supervised by a specialist ELC Group R&D team. The project involves the development of a novel influenza vaccine. The team embodies several experts on regulatory vaccines, current advisers to the WHO. With their project team housing nationalists from 38 countries speaking more than 54 different languages, the company surges forward with the strategic advantage that the team possesses to interact with clients from varied geographies. Its seasoned teams of subject matter experts who have handled important positions within the industry and regulatory agencies have ample expertise in product developments and registrations across the globe. "Our ambition is to make an impact in the healthcare sector and improve the lives of many,” adds Akhil Jain.

Furnishing a Portfolio of Leading-edge Products
With its new product portfolio which is currently in development, ELC Group aims to spread its roots to encompass a wide range of therapeutic areas including oncology, cardiovascular treatment, diabetics and pain management. The products were chosen on the basis of a couple of criteria that included global market size, therapeutic categories and annual drug sales, to name a few. The company states that a few of the products are being developed with very specific IP considerations and so will qualify as paragraph IV filings in the US, 505 b2 applications in the US and Hybrid applications in the EU. ELC Group plans to market the products – which are being developed by a specialist team at the ELC Group R&D laboratories – across the US, EU, LATAM, MENA and China. Confident about generating around 2 billion USD in its annual sales after the initial launch, ELC Group intends to sign in key strategic global partners for Licensing and Distribution.

The 2011 established company has achieved exceptional growth over the past few years. With an year-on-year growth of 35 percent over the last 4 years, ELC Group has enjoyed a 51 percent growth from the last year alone. It has set its sights on achieving a growth of 60 percent by next year, and with its unswerving focus on the R&D and improving market access of medicines,the ISO 9001:2008 certified ELC Group is on the lookout for new challenges, complex products, niche products, difficult markets and branded generics. Besides, while seeking partners for its outcome-based drug co-developmental projects, the company is all ready to welcome new and spirited partners who share the same vision as the company while helping these partners to fulfil their market potential.