INOSOLVE Consulting
Spearheading Innovation In Compliance And Quality Consulting

Conceiving a potentially game-changing business idea is one thing; putting that idea into action and changing the game is a whole different story.

Being an entrepreneur is more than just filling a market gap and having the foresight to see what others don’t.

Philipp Hammer-Purgstall has been there, done that.

Working in the pharmaceutical paradigm for over two decades, Hammer-Purgstall had developed deep insights about the intricacies of quality management processes and several internal departments linked to it. This rich industry experience was instrumental in planting an exciting entrepreneurial seed that continues to shape the way he approaches challenges faced by pharmaceutical, biotechnological and medical device companies. Following his entrepreneurial spirit, he decided to roll the dice and bring in innovative strategies and solutions to meet the diverse challenges head-on. INOSOLVE was born.

“I started INOSOLVE alone with the focus on GMP consulting and banked on my experience worth 17 years working in reputed pharmaceutical companies,” begins Hammer-Purgstall, founder and CEO, INOSOLVE.

INOSOLVE specialises in the dynamic realms of pharmaceutics, biotechnology, and medical device, wherein the most crucial commonality shared by these industry verticals is the stringent regulatory compliance standards. Introduced to ensure health safety, improve quality, and reduce the risk factors, the compliance norms play an indispensable role in governing the entire lifecycle of any healthcare enterprise. However, the world of regulatory compliance is intertwined and requires deep-seated knowledge to understand its many intricacies accurately. Time and again, the lack of expertise compels pharma, biotech, and other health-associated firms to divide their focus between regulatory compliance and drug development, making it difficult for them to remain compliant and productive, both at the same time. This is precisely where INOSOLVE is turning the tide in favour of these enterprises.

INOSOLVE applies intelligent and innovative strategies to mitigate clients’ challenges and helps them achieve long-term success. Be it life sciences and health care consulting, quality management and auditing, regulatory compliance, toxicology and R&D, qualification and engineering, or project management, the company’s highly qualified and active team offers valuable advice. It helps customers navigate the complex realm of quality assurance and validation.

At the outset, Hammer-Purgstall mentions, INOSOLVE focused on handling the typical quality assurance and management challenges of its clients. Infusing his expertise as a technical engineer, Hammer-Purgstall gradually delved deeper such as assessing the areas of cleanrooms in biopharmaceutical plants, streamlining the upstream/downstream processes of it, and even helping pharmaceutical clients select the ideal equipment.

As years rolled by, INOSOLVE gathered experience, gained momentum, and began upgrading its services. From being a one-man show to now having more than 35 employees onboard, INOSOLVE has come a long way.

Today, the company’s broad spectrum of knowledge and proficient consultants enable it to handle multiple big projects and help clients become ‘intellectually ready’ to steer through the compliance panorama.

Our holistic, stepwise approach allows customers to focus on their corporate liabilities while we help to overcome their old structures along quality based and practical standards

Steering Processes from Compliance to Enhanced Quality

At heart, INOSOLVE offers quality management services, creates/implements supplier qualification and re-qualification processes, analyses and handles Deviations, Change and CAPA-Management in remediation projects, applies a preventive procedure to maintain traceable standards, and others. Another important core area of INOSOLVE is Qualification/Validation of equipment and processes for almost all areas. This includes amongst others also a brought knowledge and experience in Cleaning Validation and Sterilization Validation as well as in Computerized System Validation. Besides, the company also offers interim management services to either fill in the shortage of staffs or act as a specialist to guide clients in conducting specific vaccine programs, analysing blood products, and others. The Austria-based firm with a subsidiary company in Germany also supports clients in their supplier audits and ensures they adhere to applicable guidelines such as GMP, GLP, GDP, and others. INOSOLVE also helps clients in paper-based documentation work, on-site calibration of medical equipments, and management of the client’s measuring devices.

Besides the plethora of innovative services that INOSOLVE brings to the table, Hammer-Purgstall views the company’s collective industry expertise and experience as the winning differentiator. “We draw our strength from our network competence. Our team of consultants are highly qualified, committed specialists who have worked in the industry for many years,” informs Adolf König, Director Quality Management & Auditing, INOSOLVE. Unlike its competitors that have limited their knowledge and specialisation to any one aspect of compliance, König highlights that the dexterity of INOSOLVE’s employees knows no bounds. The company utilises the wide-range competencies of its team from different domains of regulations and blends it with the ingrained expertise of Hammer-Purgstall to effectively devise solutions that serve clients better.

Combining Creativity and Know-How

What makes INOSOLVE second to none is the comprehensive teamwork that enables it to solve clients’ impediments ‘hands-on.’ Instead of relying on the proficiency of a single individual, the company combines the deep-rooted knowledge of each of its employees to address any challenge that arises in the compliance landscape. Be it maintaining data integrity or managing the need for additional calligraphers, organising regulation blocks within a company, or setting up a communication plan, INOSOLVE’s consultants are systematically assigned according to the individual needs of a customer’s project.

The company collaborates with its clients and lays out a plan of action that is cost-effective and enhances productivity.

Creativity forms the core of INOSOLVE. With interdisciplinary teamwork fuelling its efforts, the company takes an integrated approach to find innovative strategies for its customers. Hammer-Purgstall explains that often clients struggle with their legacy compliance frameworks and find it difficult to function or revamp the same. INOSOLVE not only offers such clients with a systematic and integral overview of their organisation but also brings under focus unprecedented opportunities to redefine their business architecture. In addition to compliance, INOSOLVE also helps customers reduce their complexities as well as fulfill the necessary GxP requirements within a short time. “Our holistic, stepwise approach allows customers to focus on their corporate liabilities while we help to overcome their old structures along quality based and practical standards,” expresses Hammer-Purgstall.

Solving Longstanding Customer Challenges

Hammer-Purgstall has succeeded in building INOSOLVE as a ‘real partner’ for its clients. Acting as the pillar of support, it propels customers to the helm of success. Since its inception, the company has orchestrated over 150 success stories–ranging from dental offices to global players in the pharmaceutical business.

To further illustrate how INOSOLVE mitigates its clients’ complexities, Hammer-Purgstall cites a case study when they worked on a remediation project with a client. After initial analysis, the INOSOLVE team realised that it was a hard nut to crack. The quality management system wasn’t updated, lacked essential qualification standards, and had insufficient information, thereby negatively impacting the data integrity of the client’s process. INOSOLVE did a comprehensive inspection and provided an overview of the problems to the client, before presenting them with several ways in which they could solve the issues. The client realised that it was not only a technical problem, but they also needed a cultural change process. When they turned to INOSOLVE, the team readily helped them fix the inconsistencies. Throughout the ongoing project, the client witnessed continued growth and betterment, which only stands to highlight the value proposition INOSOLVE brings to the pharmaceutical and biotech space.

Setting a Course toward Growth and Success

Continuing on this successful streak of facilitating unparalleled growth to clients, INOSOLVE is making significant inroads into establishing itself as a leader in the compliance landscape. With branches presently in Austria and Germany, INOSOLVE is creating wavelets not only in Europe but also in several parts of the North America and Asia. “Besides, we are also working with multiple authorities from all over the world. This allows us to handle regulations of different cultures efficiently,” asserts Hammer-Purgstall. At the outset, INOSOLVE even holds a broad experience in dealing with blood establishment, plasma compositions, vaccinations, and others. In the years to come, the pharmaceutical and biotech sectors will undoubtedly witness significant contributions from INOSOLVE in regard to compliance as the company prepares to augment its services and offerings further.