First Pharma Consultants, LLC
The Right Formula for Pharmaceutical Compliance & Technology

As a highly regulated sector, the pharmaceutical industry is different from the rest of the sectors in many ways. For instance, pharma companies often struggle to deal with complex regulations and compliance throughout their design and engineering process. Be it the design, construction, or validation of a facility, it is important for pharma companies to maintain superior standards in all aspects of engineering and meeting regulatory needs. First Pharma Consultants, a pharmaceutical consultancy company, helps pharma companies accomplish this goal by providing bespoke solutions to meet their engineering and regulatory needs. “We provide quality compliance systems to meet the regulatory and compliance requirements mandated by various regulatory bodies,” mentions Gary Custis, President/CEO of First Pharma Consultants.

The company provides engineering design, project management, and compliance solutions to the Pharmaceutical, Biopharmaceutical, Medical device, Pharmacy 503a, and Human Drug Outsourcing facilities (503b). Additionally, they undertake both brownfield and greenfield building projects and perform design, validation and commissioning of buildings, facilities, and equipment to help them adhere to quality compliance requirements. The company also minimizes the risks involved in the production environment with its expertise in cGMP systems and enables laboratories, micro labs, cold storage, and warehouses to achieve the desired efficiency.

Although clients approach First Pharma Consultants with diverse requirements, most of them need help with facility design. The company understands the regulatory requirements related to building design better than anyone. First Pharma Consultants design the facilities and comply with the standards mandated by various regulatory bodies such as the FDA and EU. Be it hazardous compounds, active pharmaceutical ingredients, solid dosage, or liquid manufacturing, the company designs facilities that meet compliance requirements. As many companies lack an in-house engineering team, the company deploys their project managers and engineers to assist the client with their capital projects. Although First Pharma Consultants is a boutique consultancy firm, its professional relationships with companies help provide full-service engineering services, which come in handy should the need arise.

We provide quality systems to meet the regulatory and compliance requirements mandated by various regulatory bodies

When a potential client approaches First Pharma Consultants with a specific requirement, the company engages with their functional teams to understand the project outcomes. They communicate extensively with scientists to understand bottlenecks and find ways to overcome them. During such an engagement, they understand the client’s existing processes, capabilities, and budget. First Pharma Consultants tries to stay within the client’s budget and meet their schedule. Subsequently, they work toward meeting the client’s needs by delivering quality service. “Whether it’s a new or renovated facility, we ensure that clients are satisfied with the final outcome,” mentions Mr. Custis.

In one instance, First Pharma Consultants had to handle the renovation of three different sites at a time. The project involved designing six laboratory buildings, and they had to collaborate with over 250 scientists. As they had to consider every member’s opinion, getting them on the same page was a significant challenge. The company built a logistics plan that allowed them to renovate the spaces while keeping them in operation. The client closed down one of their sites and moved their people to other sites to start the renovation. First Pharma Consultants accomplished this by communicating extensively with managers and directors and a logistics team who executed the plan. As they understood the client’s business priorities and coordinated with multiple teams, they completed the project within the deadline.

Such success stories stem from First Pharma Consultant’s commitment to improving its client’s processes and infrastructure by leveraging the expertise of its consultants. As their consultants are located remotely and enjoy the flexibility to visit the sites located across the country, First Pharma Consultants can deploy them quickly and serve the clients better. For that reason, unlike their competitors, they can keep the costs lower while offering their services. Although First Pharma Consultants’ services come at a lower price point, they never compromise on quality and safety. As they keep quality and safety at the top of its board room agenda, they never take shortcuts while addressing the client’s issues.

Moving ahead, the company plans to focus more on pre-auditing and inspections and help clients interpret the changing regulatory compliance requirements. They also plan to focus on computer system validation to ensure the efficacy and effectiveness of the system.