Services
Overview
No matter your size — whether you are a leading medical device manufacturer, a growing biotech startup, or a global pharmaceutical company — Encore Biotech provides expert guidance in regulatory, scientific, and business strategies for medical products.
Our team includes former FDA regulatory experts with years of hands-on experience. We understand the complexities of product development and approval, combining deep scientific expertise, extensive regulatory knowledge, and clear communication to drive successful FDA interactions.
Why Choose Encore Biotech?
- Comprehensive Expertise in R&D, regulatory affairs, and quality assurance
- Tailored Solutions to streamline product development and accelerate approval
- Proven Success in guiding innovative medical products to market
Please call or email us so we can help you navigate the challenges of bringing safe, effective, and innovative products to patients.
Regulatory Strategy & Compliance
- Regulatory pathway assessment for medical devices, pharmaceuticals, and combination products
- Guidance on FDA and global regulatory submissions (IDE, PMA, de novo, 510(k), 513(g), IND, etc.)
- Preparation and support for FDA meetings, Q-submissions, and regulatory negotiations
Scientific & Technological Solutions
- Product design consulting to optimize performance and compliance
- Scientific problem-solving to overcome technical and regulatory hurdles
- Validation strategies for analytical, clinical, and manufacturing processes
Quality Assurance & Compliance
- Development of quality systems aligned with FDA, ISO, and GMP standards
- Risk management strategies to ensure product safety and reliability
Audits, gap assessments, and remediation plans for regulatory compliance
Market Access & Commercialization Strategy
- Competitive landscape analysis and go-to-market strategies
- Scientific communication and positioning for regulatory and commercial success
- Support for reimbursement and health economics planning