About Global Restructuring Advisors
In the years since our founding, GRA has built an unprecedented record of archievement, assisting clients all over the globe to address nonclinical as well as clinical product development and regulatory challenges.
Our team of experts possess unmatched insight and experience in both the regulatory and and product development processes. Many have held positions within regulatory agencies and/or were senior leaders with industry experience, and during their careers have played instrumental roles in crafting the policies and procedures is use today. Our professionals have hands-on industry experience and the knowledge to successfully navigate through the complex strategic-regulatory process.
GRA’s expert team works together from around the world through digital channels, reducing costs for clients. We combine our knowledge for you without the need for expensive offices or extensive support staff.
We are a full-service regulatory and product development consultancy for health care products and act as a full-service consultant for companies large and and small seeking to bring innovative, safe and effective products to market.
GRA offers comprehensive knowledge and many years of experience in the most important markets for medical products worldwide. Our services are focused on assisting medical device, pharmaceutical and biological companies across the globe achieve regulatory and standard compliance with U.S., European and Latin-American agencies and organizations. The expertise of the consulting team enables you to overcome the hurdles of the respective region.
Furthermore, our specialists with long-time industry know-how analyze your company’s problems, design solutions and implement them in your company in a target-oriented manner.
GRA’s team of experts has good relationships in the venture capital and private equity sectors. Thanks to our experience, it is easy for us to identify the right investors and address them in a targeted manner. We also advise you on the structuring of the investment and the associated due diligence processes.
0
GRA References
GRA References
Successful startup company offering a non-invasive liver function monitor using advanced laser technology. Humedics LiMAx device can replace invasive liver biopsies and is growing to become the world-wide diagnostic standard in the huge NASH / NAFLD market.
GRA team member(s) set-up clinical trials and an IIT program to support the international growth strategy and helped to established partnerships with big international pharma players.
Manufacturer and national market leader in non-invasive hemodynamic monitoring devices, the “T-Line company”.
GRA member(s) support company in new product development and medical device marketing and sales and accompany national clinical trials program and strategy.
Endoscopic instrumentation which enables doctors to treat lumbar spine conditions with utmost safety, precision and effectiveness.
GRA team member(s) supported the corporate business development of a novel less invasive spine surgery approach. Also, GRA grew the distribution sales network and assisted in regulatory and compliance matters in US/LATAM. GRA strengthened the supply chain processes.
Polish national market leader with a vast range of (OTC) over-the-counter products and medicines.
GRA team member(s) supported and advised USP in creating and setting up a complete new medical device range, complementing the existing pharmaceutical brands and products.
MacroPore, specialist for implants that fix bone defects and dissolve in the body without residue.
GRA team member(s) obtained 20+ FDA clearances, 10+ European Union CE Marks and 25+ other international approvals for bioresorbable products in countries such as China, Korea, Singapore, Thailand and Australia.
Production and distribution of inexpensive, high-quality pharmaceuticals manufactured in Germany.
GRA team member(s) lead the Strategic regulatory support incl. maintenance of compliance for consumer health medical devices in USA/CAN, Japan and LATAM.
Provider of a unique and only combined liver, lung, kidney support device for advanced intensive care therapy. Advitos has won several international awards for growth and innovation.
GRA team members(s) established sales and marketing structures from scratch and built up a key opinion leader network to achieve triple digit sales growth.
Funds that invest in early stage and high-growth companies with unique technology.
GRA team member(s) lead Senior Advisory incl. translating technologies through a novel deal filtering process in order to understand and create value early. Supervision and due diligence for different technologies such as pain tracking, in-vitro liquid biopsy and imaging of perfusion, where also done by GRA.
Swiss company with focus on the performance and growth of promising technologies in the life science industry
GRA team member(s) managed the Senior Advisory development of early stage life science technologies including the implementation of a novel out licensing and early partnering approach.
iOS and Android based Augmented Reality Technology which tests the functional & cognitive aptitude of a patient, via a self-learning (ML) algorithm.
GRA team member(s) lead the Installation of regulatory approval processes and compliance in EU/US and LATAM for the non-invasive early diagnosis of neurodegenerative diseases.
Manufacturer of the only successful non-invasive hemodynamic monitoring system using radial applanation tonometry.
GRA team member(s) restructured the company and product portfolio and achieved the successful trade sale to a Chinese partner.
Tensys’ devices today are the most used non-invasive hemodynamic monitoring devices in mainland China.
One of the market leaders in medical technology. Medtronic is known for its pacemakers. More than half of all pacemakers implanted worldwide are manufactured by Medtronic.
GRA team member(s) involved with medtronic were responsible for many industry firsts including: The first bioresorbable spinal plate and screw system 510(k) cleared by FDA, the first bioresorbable cranial-facial distraction system 510(k) cleared by FDA, and the first bioresorbable spinal interbody device CE Marked in the European Union.
World market leader in advanced hemodynamic monitoring systems, the “PiCCO-Company”.
GRA team member(s) in various positions strongly participated in growing the company from small start-up to market leader.
Industry leader in regenerative medicine. Manufacturer of many industry firsts in the regenerative medicine space, globally.
GRA team member(s) are active in leading regulatory positions affecting the American and Asian markets.
Funds that invest in early stage and high-growth companies with unique technology.
GRA team member(s) lead Senior Advisory incl. translating technologies through a novel deal filtering process in order to understand and create value early. Supervision and due diligence for different technologies such as pain tracking, in-vitro liquid biopsy and imaging of perfusion, where also done by GRA.
Endoscopic instrumentation which enables doctors to treat lumbar spine conditions with utmost safety, precision and effectiveness.
GRA team member(s) supported the corporate business development of a novel less invasive spine surgery approach. Also, GRA grew the distribution sales network and assisted in regulatory and compliance matters in US/LATAM. GRA strengthened the supply chain processes.
Production and distribution of inexpensive, high-quality pharmaceuticals manufactured in Germany.
GRA team member(s) lead the Strategic regulatory support incl. maintenance of compliance for consumer health medical devices in USA/CAN, Japan and LATAM.
Swiss company with focus on the performance and growth of promising technologies in the life science industry
GRA team member(s) managed the Senior Advisory development of early stage life science technologies including the implementation of a novel out licensing and early partnering approach.
iOS and Android based Augmented Reality Technology which tests the functional & cognitive aptitude of a patient, via a self-learning (ML) algorithm.
GRA team member(s) lead the Installation of regulatory approval processes and compliance in EU/US and LATAM for the non-invasive early diagnosis of neurodegenerative diseases.
Manufacturer of the only successful non-invasive hemodynamic monitoring system using radial applanation tonometry.
GRA team member(s) restructured the company and product portfolio and achieved the successful trade sale to a Chinese partner.
Tensys’ devices today are the most used non-invasive hemodynamic monitoring devices in mainland China.
One of the market leaders in medical technology. Medtronic is known for its pacemakers. More than half of all pacemakers implanted worldwide are manufactured by Medtronic.
GRA team member(s) involved with medtronic were responsible for many industry firsts including: The first bioresorbable spinal plate and screw system 510(k) cleared by FDA, the first bioresorbable cranial-facial distraction system 510(k) cleared by FDA, and the first bioresorbable spinal interbody device CE Marked in the European Union.
MacroPore, specialist for implants that fix bone defects and dissolve in the body without residue.
GRA team member(s) obtained 20+ FDA clearances, 10+ European Union CE Marks and 25+ other international approvals for bioresorbable products in countries such as China, Korea, Singapore, Thailand and Australia.
Manufacturer and national market leader in non-invasive hemodynamic monitoring devices, the “T-Line company”.
GRA member(s) support company in new product development and medical device marketing and sales and accompany national clinical trials program and strategy.
Industry leader in regenerative medicine. Manufacturer of many industry firsts in the regenerative medicine space, globally.
GRA team member(s) are active in leading regulatory positions affecting the American and Asian markets.
Provider of a unique and only combined liver, lung, kidney support device for advanced intensive care therapy. Advitos has won several international awards for growth and innovation.
GRA team members(s) established sales and marketing structures from scratch and built up a key opinion leader network to achieve triple digit sales growth.
Successful startup company offering a non-invasive liver function monitor using advanced laser technology. Humedics LiMAx device can replace invasive liver biopsies and is growing to become the world-wide diagnostic standard in the huge NASH / NAFLD market.
GRA team member(s) set-up clinical trials and an IIT program to support the international growth strategy and helped to established partnerships with big international pharma players.
World market leader in advanced hemodynamic monitoring systems, the “PiCCO-Company”.
GRA team member(s) in various positions strongly participated in growing the company from small start-up to market leader.
Polish national market leader with a vast range of (OTC) over-the-counter products and medicines.
GRA team member(s) supported and advised USP in creating and setting up a complete new medical device range, complementing the existing pharmaceutical brands and products.
0
Team
0
His fields of expertise comprise advising on transactions with respect to corporate law and transformation law. With a view to listed companies, Dr. Maass provides comprehensive advice on follow-up obligations under capital market law and communicative aspects such as company reports. In addition, he provides advice to medium-sized companies and funds as well as their shareholders and advisory boards in the context of reorganisation and restructuring measures.
Current and past projects include advising:
A leading listed company in the area of communication technology regarding the corporate restructuring and the merger of several subsidiaries.
A major investment company on its reorganisation in connection with new European legislation.
Various listed companies regarding post-admission obligations (ad-hoc notifications, voting rights).
Additional information:
(Dr. Oliver Maass acts as Global Restructuring Advisors representative according to the GDPR. For more information please visit our Privacy Policy.)
He worked as CEO and COO of several mid-sized companies internationally operating in the segments medical device technology, pharmaceuticals and biotech.
Current and past projects include:
Implementing of an international growth strategy and establishing subsidiaries worldwide. The development of operations and supply chain structures, whilst addressing regulatory affairs and implementing official regulations, as well as entering into licensing agreements and strategic alliances with globally operating companies.
Repositioning of a company and enhancing products by developing new technlogies and implementing country specific marketing and sales strategies for the chinese marketplace.
Strategic new positioning of a biotechnological active ingredient for new applications and acquiring new investors.
Current and past projects include:
The first european approval for a point-of-care medical device to process regenerative medicine cells from adipose tissue, as well as the first industry approval for novel enzymes to extract the regenerative medicine cells at the point of care.
He has been at the forefront of regenerative medicine laws in Japan and Europe to positively affect the legal language and interpretations of existing and emerging regulations.
Mr. Kleinhenz has obtained 20+ FDA clearances, 10+ European Union CE Marks and 25+ other international approvals for bioresorbable products in countries such as China, Korea, Singapore, Thailand and Australia.
As an industry executive, he has 18 years of international experience in clinical research, medical marketing/product management, sales of highly ethical and complex medical devices, pharmaceuticals and drug-device combinations.
He has a huge network of partners and opinion leaders in Cardiology, Surgery, Intensive Care, Nephrology and Hepatology.
Current and past projects include:
C-Level leaderships, VP positions in market-entry, growth strategy and restructuring.
Implementation/improvement of sales and marketing teams, product development, and intelligent sales models.
His activities span over Europe, US, and China, but also Japan, Russia, and South America.
In 2020, Sumita co-founded The Pro Safety Group- a platform bringing the latest education, technologies and protocols in safety to the beauty industry.
Sumita Cosmetics was her brainchild and eponymous brand. She sold the company in 2017 after expanding it to 22 countries. Sumita is currently the Operating Partner in a brand consulting firm that provides strategic advice and solutions to global brands and executives in today’s competitive landscape. Her focus is in medical devices and technologies that are on the cutting edge of making a global impact. She also serves as the CEO of Ziba Services.
She is an author/speaker on topics ranging from entrepreneurship, women’s empowerment, and brand building. She has an extensive network in N. America, Europe and Asia. Her pride is her versatility, strong work ethic, facilitating partnerships and long working relationships.
Throughout his career Dr. Richard Fischer has developed a great reputation in building highly profitable companies in the global medical device arena and has raised substantial amounts of funds from VC’s and private investors.
He has successfully implemented international valuable growth strategies for multiple international medical device companies and repedatly established subsidiaries in both US and EU markets.
His visionary approach to achieve sales & revenue and his honest passion to constantly rethink business models makes him the perfect fit to lead international active medical device companies.
He has successfully worked for medium-sized and large German companies in the field of IT engineering and IT management.
Mr. Tomitzek describes himself as a technology evangelist and is known to find solutions at the interface between product development and secure structural systems, which enable rapid and progressive cooperation of all parties involved.
He has studied law and worked successfully for medium-sized and large companies from many different sectors.
In past projects he developed strategies for digital product marketing and the most effective appearance of companies on digital networks and search engines.
She holds a BSc. Degree in Busines Administration and is continuing her scientific career in business management with a focus on digital project management at ESCP Europe.
On past projects she has supported various clients in developing effective marketing and pitch materials to drive business development and to optimize strategic positioning. Additionally, she has conducted market research to identify potential business opportunities.
We take a holistic and integrated view of what is happening in lifesciences today and help your company to manage the future.