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We take a holistic and integrated view of what is happening in lifesciences today and help your company to manage the future.

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We take a holistic and integrated view of what is happening in lifesciences today and help your company to manage the future.

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  • We guide lifescience companies all over the world through the product development process from concept to commercialization, assisting them in bringing safe, effective and innovative healthcare technology, both analogue and digital, to market.

  • Your Gateway to USA, Europe, LATAM and Asia GRA is a full-service strategic-regulatory and product development consulting firm for entrepeneur´s and health care solution providers.

  • Our team is composed of subject-matter experts with decades of regulatory or industry experience – which we leverage to craft solutions to your development or regulatory challenges, regardless of your product type or development pathway.

  • Since our launch in 2011 we´ve helped multiple companies to navigate through their non-clinical and clinical development, strategic-regulatory or compliance challenges.

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Over 200 years of cumulative healthcare and lifesciences experience on staff
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Earned a 100% success rate in first time ISO, CE and LATAM certification
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> hundreds of products pushed through various pathways of FDA

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Markets

Europe

EU MDR / EU Medical Devices Regulation 2017,745 (MDR) / MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) / GCP and ISO 14155 Compliance / ISO 13485:2016 / Medical Device Vigilance and Incidence Reporting / European CE Marking for In Vitro Diagnostics / QMS Compliance / CE Marking for Medical Devices / Telehealth & Mobile Apps / PMCF / Clinical Trial Data Management / QA & RA Services/ European Authorized Representative / iVDR 2017.746

USA

US FDA 510(k) / FDA QSR (21 CFR 820) / US FDA Medical Device Classification /  Medical Device Single Audit (MDSAP) / US FDA Official Correspondent / FDA eMDR / Medical Device UDI / Medical Device CFG / QMS Compliance / FDA IVD / Telehealth & Mobile Apps / US FDA Pre-Sub (Q-Sub) / ISO 14971 / ISO 13485 / US FDA Form 483 / QA- & QR Services/ US FDA Agent Representation

ASIA

PMDA Medical Device Registration / JMDN Consulting / JMDN Code Research / Quality Management System Compliance with Japan Ordinance 169 / MDSAP / PMDA Registration for In Vitro Diagnostics (IVD) / Foreign Manufacturer Registration / Telehealth & Mobile Apps / ISO 14971 Risk Management / QMS Audits / ISO 13485 & FDA QSR Audits / QA & RA Services

LATAM

ANVISA Medical Device Registration and Approval in Brasil / Brazil GMP Quality System Compliance (BGMP) / ANVISA Registration Holder Service / MDSAP / Medical Device Vigilance Reporting for ANVISA / Brazil INMETRO Certification / QA & RA Outsourcing / COFEPRIS Medical Device and IVD Registration and Approval in Mexico / Mexico Registration Holder / Medical Device Vigilance Reporting in Mexico / Classification of Medical Devices in Mexico / INVIMA Medical Device Registration and Approval in Colombia / Colombia Legal Representation for Medical Device Companies

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About us

Our team of experts possesses 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 in use today. Our professionals have hands-on industry experience and the knowledge to successfully navigate through the complex strategic business development and clinical-regulatory processes.

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Services

We are a full-service strategic-regulatory-clinical 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.

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Industries

Since our launch in 2011, GRA has built a remarkable record of archievement, assisting clients all over the globe to address non-clinical, as well as, clinical product development, market access and strategic-regulatory challenges for both pharma and medical device industries.

Publications

From time to time GRA publishes recent and important updates about industry-related topics.

Latest Publications

Platform Life Sciences, Nr. 4 

GRA Senior Partner Matthias Bohn and Thorsten Schmitt about the impact of the new MDR regulation guideline.

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Why GRA ?

Broad experience and forward-thinking team.

GRA offers comprehensive knowledge and many years of experience in the most important markets for medical products worldwide. The expertise of the consulting team enables you to tackle the endeavors of your chosen region.

We help companies solve their most pressing problems, restructure their business systems and regain the trust of all stakeholders involved. Finally, we build the basis for sustainable business success based on competitive cost structures, innovation and growth.

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.

The healthcare industry is on a journey. Thus organizations need to choose the right path forward to best possible serve their market. GRA´s healthcare strategy consulting experts partner with health systems to develop a market-leading strategy for long-term top performance, growth, and sustainability.

We take a holistic and integrated view of what is happening today and help your company to prepare for the future.

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’s expert team works together from around the world through digital channels, reducing costs for clients. We combine our knowledge without the need for expensive offices or extensive support staff.