Medivdpharma – Experts in Drug-Device Combination Products
Drug-device combination (DDC) products bring powerful new treatment options—but they also face some of the toughest regulatory hurdles. With overlapping pharmaceutical and medical device requirements, compliance is complex, and approvals can be slow.
How We Help
Regulatory Strategy
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Clear, tailored plans to meet FDA, MDR, EMA, and global requirements.
Design Controls & Risk Management
- Compliance built in from the start to support safety and efficacy.
Submission Support
- Streamlined preparation for faster approvals.
Quality Systems
- Integrated solutions that align with both drug and device standards.
Medical Writing
- High-quality documentation that meets regulatory expectations.
Why Choose MIP for Combination Products?
01.
Dual Expertise
Strong pharmaceutical and medical device knowledge in one team.
02.
Seamless Integration
Consulting and medical writing under a single provider for smooth project delivery.
03.
Faster Market Access
Avoid costly missteps and delays with expert guidance.
04.
Future-Ready Compliance
We stay ahead of evolving global guidelines for combination products.
Your Advantage
Combination products are growing fast, and regulatory scrutiny is rising. With MIP as your partner, you’ll move forward with confidence—bringing safe, effective, and innovative therapies to patients sooner.