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The pharmaceutical space has been undergoing a rapid shift for the past few years. The transition from blockbuster drugs to personalized medicines has completely changed the face of the industry by enabling it to serve patients better. This, however, has prompted regulators to keep a keen eye on the quality of the medicines being produced by bringing stringent guidelines. And this regulatory landscape is becoming more volatile every day, with frequent changes and the advent of new rules. Addressing all the complex regulatory requirements is a task easier said than done for businesses—given the lack of in-house expertise and systems.
Pharmaceutical consultants, to this end, promise a feasible way forward. These entities hold years of experience in the pharma space and understand the ever-evolving guidelines. As a result, they have the capability to guide clients throughout the entire product lifecycle stages, including planning, designing, constructing, product testing, and commissioning processes. Also, by partnering with a pharmaceutical consultant, businesses can have access to cutting-edge technologies to streamline their existing mode of operation and stay a notch above the rest. This is crucial considering that pharma companies need to work under strict deadlines to meet the ever-growing market demands.
However, while partnering with pharmaceutical consultants, organizations need to have a comprehensive understanding of the services that the partner can offer and if they can be streamlined according to their business-specific needs. The consultants’ experience and expertise are also crucial factors in determining the success of a collaboration.
This edition aims to present the list of pharmaceutical consultants that have taken the industry by storm with their comprehensive services.
Let us know your thoughts.
Court Square Group is a leading provider of audit-ready compliant cloud infrastructure solutions for the life science industry. With a market presence spanning 27 years and counting, the company's core competencies comprise managed hosting, disaster recovery, and long-term archiving through its FDA 21 CFR Part 11 certified ARCC infrastructure. Additionally, Court Square Group helps clients unlock and maximize the value of their content with its ARCC-hosted, compliant, and regulated content and document management solution, RegDocs365. The solution provides real-time document visibility while enabling innovative solutions by integrating commercial grade products and embedding 21 CFR Part 11 compliance within the overall solution
Elite BioPharma Consulting offers superior clinical development and operational leadership consulting services to pharmaceutical and biotech companies. Based in Boston, they offer 60+ years of global industry experience across a wide variety of therapeutic areas in drug & device development.
Connacht M. Peterson, Senior VP Clinical Development, Jill C. Bossi, Senior VP Clinical Operations and Shawna H. Evans, Senior VP Clinical StrategyWe partner with our clients to help drive excellence in their clinical development process, from Investigational New Drug (IND)/Investigational Device Exemption (IDE) application through New Drug Application (NDA)/Premarket Approval Application (PMA) filing
Elite BioPharma Consulting
Management
Connacht M. Peterson, Senior VP Clinical Development, Jill C. Bossi, Senior VP Clinical Operations and Shawna H. Evans, Senior VP Clinical Strategy
Founded in 2009, Excite Pharma Services is a premier small-scale aseptic drug manufacturer providing analytical chemistry CMC services for APIs and drug products. Excite has the capabilities to meet both human and animal drug needs. Their cGMP sterile fill and manufacturing facility consists of four cleanrooms (ISO 5-8 certified) that handle Phase I and II hand fill operations and small-scale commercial needs for injectable products. The company's multiple aseptic hoods provide the ideal sterile environment for clinical trials and research.
Excite Pharma Services
Management
Keith Koehler, President & CEO
Stephanie Greenwood, Business Development Specialist
The company has a varied level of experience in several areas of the pharma industry and embeds itself as a true partner in their client’s organization.
Trovare Pharma Solutions
Management
Donna Bonarrigo, Managing Director at Trovare
Catenion is a management consulting firm devoted to helping life science companies create more innovative and effective strategies to significantly increase their ROI. Their value lies in being able to help clients better assess the values and risks of their products, projects and portfolios, in order to make more informed investment decisions
Nitto Avecia Pharma Services is a world class contract development and manufacturing organization supporting the pharmaceutical, biopharmaceutical, and medical device industries. Their comprehensive suite of services streamlines processes to accelerate time-to-market. With more than 30 years’ experience, they have deep scientific expertise across a range of products, with a special focus on oligonucleotides
As one of the world's leading global clinical research organizations (CRO), Parexel International Corporation provides the clinical development capabilities and integrated consulting expertise it takes to streamline development every step of the way — faster and more cost-effectively As one of the world's leading global clinical research organizations (CRO), Parexel International Corporation provides the clinical development capabilities and integrated consulting expertise it takes to streamline development every step of the way — faster and more cost-effectively
PRMA Consulting is the go-to consulting partner, using insight-based strategic consultancy and transformative digital applications to deliver smarter market access solutions. Their vision is to enable faster patient access to therapies that improve health outcomes. Their culture of excellence, respect, and collaboration presents unique opportunities for their colleagues and the clients that partner with them
Visikol is a contract research services company that is focused on accelerating the drug discovery and development process through providing its clients with advanced tissue imaging and advanced cell culture services. The company provides end-to-end services that include 3D tissue imaging, multiplex tissue imaging, digital pathology, high content imaging, 2D cell culture assays, 3D cell culture assays and ex vivo tissue slice assay
Wavelength is a customer-focused backward-integrated world-class developer and manufacturer of Active Pharmaceutical Ingredients (APIs). It is the independent company of choice for pharmaceutical industry leaders that require advanced API solutions and reliable supply to gain sustainable competitive advantage. The company is on the same wavelength as its customers – a partner in tune with the results required to best support their needs