Strategic Development for Every Regulatory Pathway 

At MedPharm, we understand that each regulatory product type comes with its own set of expectations, challenges, and strategic considerations. That’s why we offer fully integrated development and manufacturing support tailored to the specific regulatory pathway your product is following.

Whether you’re developing a generic, advancing a new chemical entity (NCE), or reformulating a legacy therapy for a 505(b)(2) submission, MedPharm’s scientific and regulatory experts work alongside your team to align every step of the process with global health authority standards.

Our deep experience across FDA, EMA, MHRA, and other global agencies ensures your product is built for approval—and for long-term commercial success.

We Support the Following Product Types:

Generics (ANDA & Hybrid Submissions)

Bringing cost-effective alternatives to market with precision. We specialize in topical and transdermal generics requiring Q1/Q2 sameness, IVRT/IVPT bioequivalence, and complex product-specific guidance compliance.

• ANDA formulation development
• Reverse engineering & Q1/Q2 matching
• Bioequivalence testing via IVRT/IVPT
• FDA and EMA hybrid application support

New Chemical Entities (NCEs)

Innovative formulations built from the ground up. MedPharm supports NCE development with complete preformulation, analytical, in vitro testing, and clinical supply services.

• Early formulation screening & prototype development
• Stability and container compatibility studies
• In vitro absorption modeling for regulatory insight
• IND, CTA, and NDA preparation

505(b)(2) / Hybrid Products

For differentiated reformulations, new routes, or expanded indications, MedPharm offers full support for hybrid products that bridge innovation and regulatory precedent.

• Route-of-delivery transitions (e.g., oral to topical)
• Novel delivery systems (foams, sprays, patches)
• Combination or layered data packages
• Clinical bridging and regulatory strategy support

OTC & Rx-to-OTC Switch Programs

Expand access with safe, user-friendly topical and transdermal therapies for the consumer health market.

• Patient-centric formulation design
• Sensory optimization and aesthetic refinement
• Labeling, preservative, and packaging strategy
• Monograph compliance and global OTC registration support

Combination Products 

Drug-device and dual-action formulations with complex integration requirements. We specialize in systems where delivery methods are inseparable from formulation performance.

• Patch systems with integrated adhesives
• Metered-dose spray devices
• Regulatory strategy for EU/US classification
• Human factors and usability consultation

Why MedPharm?

• Regulatory Fluency Across Markets: From FDA and EMA to MHRA and ROW jurisdictions
• Tailored Development for Each Pathway: We don’t retrofit services—we design them around your strategy
• Analytical, and Formulation Teams: Integrated support to avoid silos, delays, and surprises
• Success Across Product Lifecycles: From early feasibility to post-approval variation management

The Right Partner for the Right Path

Your regulatory pathway defines how your product is developed, tested, and brought to market. MedPharm ensures that each formulation, study, and submission is aligned with your approval strategy—backed by deep expertise, rigorous science, and global compliance.