Optimizing Life Science Industry
Your partner in Pharmaceuticals and Medical Devices
About Us
VRC Strategy is a pharmaceutical and medical device consulting service with over a decade of global experience. With over 10 years experience in diverse markets including Europe, the USA, the UK, the Middle East, North Africa, Asia, and Russia, VRC Strategy brings a wealth of knowledge and expertise to complex regulatory, quality, commercial, and operational challenges.
VRC Strategy has a deep understanding of international regulatory frameworks, including FDA, EMA, MHRA, and various regional authorities. They have successfully led teams in launching and commercializing innovative products, navigating complex reimbursement landscapes, and building strong partnerships with healthcare providers and payers.
The company leverages their international network and local expertise to deliver tailored solutions.
VRC Strategy is passionate about improving patient outcomes and driving growth in the healthcare industry. They are a strategic thinker with a strong focus on execution and a collaborative leadership style.
Worldwide presence
We partner with local consultants to help navigate through geographical compliance and regulations.
Regulatory Affairs
Medical Devices,
Pharmaceuticals
Though two distanced fields, our company can help you navigate through regulations of Medical Devices as well as Pharmaceuticals.
Europe - MDR / EMA
Our team of experienced regulatory consultants provides comprehensive guidance to help you navigate the complex regulatory landscape of the European Union Medical Device Regulation (EU MDR), European Union Pharmaceutical Regulations and Good Manufacturing Practice (GMP) regulations. We offer a range of services, including regulatory strategy development, technical documentation review and gap analysis, certification and life cycle management and SOP writting.
USA
Our team of experienced regulatory experts provides comprehensive guidance to help you navigate the intricate U.S. FDA regulatory landscape for both medical devices and pharmaceuticals. We offer a range of services, including early regulatory strategy development, regulatory submission preparation and review, FDA interactions and communications, and post-market surveillance and compliance.
Rest of the World
We support clients in developing and executing global market entry strategies. Our local teams ensure regulatory compliance in key markets, including Asia Pacific, South America, Middle East and Africa.
By leveraging our deep understanding of diverse regulatory landscapes, we help clients navigate complex regulatory requirements and optimize their global regulatory strategies. We streamline the process by developing efficient, consolidated regulatory roadmaps that address the specific needs of each market, ultimately saving time and resources.
Market Access
Market Research
-
Market Segmentation
-
Market Access Landscapes
-
Health Economic Models
-
​Consumer Insights
-
Market size and Forcasting
Competitors Landscape
-
Competitive Landscape research
-
Market Landscape Analysis
-
Positioning Analysis
-
Marketing and Sales Strategy
-
Strategy Recommendations
Pricing and Reimbursement
-
International Pricing and Reimbursement
-
Multi-Country Availability
-
Pricing and Reimbursement Strategies
-
Strategic Consulting for Pricing and Reimbursement Pathways
-
Comparative Pricing Analysis
-
International Reference Pricing (IRP) Services
-
Submissions
Payer & HTA Engagement
-
HTA Submissions
-
Payer Relations
-
Market Access Strategy
Distribution
We diligently maintain relationships with distributor around the globe where your products matter rather than being just another SKU.
Niche Market Focus
-
Target marketing
-
Target sale
Agile and Responsible Relationships
-
Smaller companies can adapt quickly to changing market conditions and customer needs, offering faster response times and more personalized service.
Strong Customer Relationships
-
Smaller distributors often have deeper relationships with healthcare providers, enabling them to build trust and loyalty.
Operations and Supply Chain
Quality Control
Provide a general description of the items below and introduce the services you offer. Click on the text box to edit the content.
Quality Management System (QMS)
We implementation and Maintenance: We help you develop and implement robust QMS to meet regulatory standards such as GMP, GDP, and GXP.
Audits and Inspections
Prepare for and conduct internal and external audits.
Training and Development
We provide comprehensive training to your quality assurance and control team to enhance their skills and knowledge.