Sandra Acosta, Director of BioPharma Solutions, EG Life Sciences
Sandra Acosta, Director of BioPharma SolutionsSince its inception, EG Life Sciences, a company of Eliassen Group, has been a leader in delivering strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. The company delivers scalable solutions with elevated subject matter experts for producing high-value results that are strategically delivered on time and within budget.

Owing to years of foothold in the life sciences space, EG Life Sciences has witnessed the unique challenges organizations across the biotech and pharmaceutical industries face. These organizations often struggle to maintain product quality and be compliant with ever-changing regulations. A lack of in-house expertise also deters these companies from performing gap or risk analyses to mitigate the operational challenges.

What makes EG Life Sciences a unique partner is the in-depth understanding of these unique challenges and the ability to deliver scalable solutions that produce optimum results. The company’s subject-matter expertise and client engagement model—which combines consulting, project management, and functional outsourcing—deliver value across the life cycle from concept to commercialization, giving them an edge over their competitors. EG Life Sciences helps companies manage their spikes in demand, keep up with the shifting priorities, and determine when to hire full-time employees or leverage consultants, all while maintaining the profitability of the business.

The recent addition of industry veteran Sandra Acosta as the Director of Biopharma Solutions is part of this strategy. Her expertise ranges across areas including project management, engineering/validation, compliance/regulatory, and sterile processes on an international scale. With over 30 years of experience in the pharmaceutical and biotechnology industries, Acosta is now involved in EG Life Sciences’ client solutions—from launching projects and providing ongoing oversight and direction to assessing and engaging talent.

“Our suite of unique and customized approaches leverages subject matter expertise in the life sciences field for our clients’ success,” says Acosta.

Organizations today turn to EG Life Sciences for advanced strategy, hands-on knowledge, and an extensive network of regulatory experts to complement their internal team. Combined with Acosta’s technical expertise, exposure to state-of-the-art processes and equipment across world-class manufacturing operations, as well as knowledge on the latest industry trends and technological advancements, the company has been instrumental in leading the expanded delivery of positive outcomes and deliverables to clients.

EG Life Sciences: Offering Strategic Consulting and Innovative Solutions to The Life Sciences Industry

For instance, a global multi-billion-dollar medical device company approached EG Life Sciences to help them overcome complex compliance challenges. It became a real struggle for them to satisfy the FDA consent decree, which prohibited the sale of their devices and the development of upgraded products. They needed a competent team to address the gaps in the existing processes.

Upon engaging with the client, EG Life Sciences appointed a team of industry-leading project managers to swiftly identify the pain points, propose a resolution, and communicate those actions to the FDA for a positive outcome.

The project managers executed a quality improvement plan that resolved a 483 Warning Letter regarding the client’s electronic infusion device. They quickly examined and documented the gaps, proposed a comprehensive remediation plan, and undertook corrective and preventative actions to address the FDA’s concerns.

Within five months, the team closed 1,906 compliance gaps in the supplier management database and more than 159 supplier audits, implementing new corporate supplier procedures. The EG Life Sciences team unearthed six additional compliance gaps and offered solutions before they could become further trouble spots.

Our tailored services help clients achieve compliance and improve cost efficiencies while helping them get products to market and keep them on the market

The remediation plan and subsequent FDA clearance allowed the medical company to quickly get back to business, saving an estimated $200 million in product recalls and other expenses. The plan also yielded a pathway for the company to resume its efforts to introduce new products to the market. This is one of several stories where EG Life Sciences has successfully impacted the operation of its partners, especially by leveraging internal quality systems and compliance programs.

EG Life Sciences’ team of biopharma professionals and veterans of the healthcare industry plays a vital role in scripting such client success stories. Be it vetting the candidates during recruiting for a client’s distinct needs, putting together a team of subject matter experts for leadership and project-based solutions, or meeting the rapid deployment requirements for scaling a project, the company’s agility and flexibility have always been deemed valuable to improve a client’s bottom line.

EG Life Sciences has more than a decade of expertise in quality assurance and control. It enables clients to respond to regulatory citations, remediate issues raised in a total of 483 warning letters, as well as design and manage Corrective and Preventive Actions (CAPA) workstreams. They also offer guidance in research and development, clinical operations, manufacturing, and supply chain, corporate and commercial operations, and biometrics.

EG Life Sciences is also investing in programs that consistently educate and train its internal team. “We foster an educational model and invite our clients and partners for informative and business-driven interactions in the form of webinars and discussions on thought leadership and market updates,” adds Acosta. Initiatives like these help EG Life Sciences maintain long-term relationships with all their clients and stakeholders, making them the go-to strategic consultants in the field.