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Optimizing Life Science Industry

Your partner in Pharmaceuticals and Medical Devices

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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.

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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.

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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.

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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.

Data Analyst

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. 

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Niche Market Focus

  • Target marketing

  • Target sale

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Agile and Responsible Relationships 

  • Smaller companies can adapt quickly to changing market conditions and customer needs, offering faster response times and more personalized service.

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Strong Customer Relationships

  • Smaller distributors often have deeper relationships with healthcare providers, enabling them to build trust and loyalty.

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Efficient Operations

  • Smaller organizations can have leaner operations, leading to lower overhead costs and potentially more competitive pricing.

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Innovative Solutions

  • Smaller distributors may be more willing to embrace innovative technologies and business models, driving industry advancements.

Operations and Supply Chain

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Sourcing & Planning

  • Sourcing execution

  • Supplier Management​

  • Demand Planning

2

Manufacturing and Packaging

  • CMO Manufacturing

  • Packaging and Labeling negotiations and oversight 

  • QP release

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Delivery

  • Global Logistics

  • Integration of Transport (Temperature Control) Best Practice 

Quality Control

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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.

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