A boutique advisory firm providing practical solutions across the medical product sector with tailored regulatory and clinical expertise
BOUTIQUE
Formed by seasoned industry executives and FDA veterans.
Strong scientific and regulatory expertise from government, industry, academia and the military health system.
Support throughout the medical product lifecycle – regulatory strategy; clinical studies; biostatistical analysis; premarket submissions; quality systems; compliance; GXP audits; remediation.
Market access considerations – CMS, private payor, military health system, DOD and VA advisory services.
PRACTICAL
Right-sized solutions with a Goldilocks approach.
While many consulting firms make recommendations that are too technical and misaligned with industry best practices, or overly generic and not specific to the very niche needs of your business –HIC solutions are “just right”.
Flexible solutions and actionable recommendations.
Valuable bridge between your company and complex regulatory requirements.
ADAPTABLE
Prioritizing continuous learning ensures HIC remains at the forefront of industry trends to deliver exceptional value.
Dual approach of specialized experience and innovative solutions.
We leverage deep understanding of regulatory compliance, market access, and product development to provide tailored solutions that address the unique challenges.
We foster strong partnerships across the industry to enhance HIC service offerings with cutting-edge insights and technologies.
TAILORED STRATEGIES FOR REGULATORY AND MARKET SUCCESS
We provide customized regulatory, clinical, and market access solutions, supporting clients from start-ups to multinational corporations with right-sized strategies.
Our specialized expertise, practical approach, and adaptability ensure personalized guidance, actionable recommendations, and compliance-driven success across the medical product lifecycle.
