Drug-Device Combination Product Consultancy Services

Our team assists in creating a comprehensive development plan that aligns drug and device components, ensuring seamless integration throughout the product lifecycle.

Establishing an effective QMS is critical for compliance. We provide guidance on:

• ISO 13485 Compliance: Ensuring that your quality management processes meet international standards for medical devices.
• GxP Compliance:Assisting with Good Manufacturing Practices (GMP) for drug components and Good Clinical Practices (GCP) for clinical trials.

We help design and implement preclinical and clinical studies necessary for regulatory submissions, including:

• Study Design and Protocol Development: Creating robust study designs that meet regulatory expectations.
• Clinical Evaluation Reports (CER): Compiling CERs to demonstrate the safety and efficacy of the combination product.

Navigating regulatory submissions for combination products can be complex. Our experts assist with:

• FDA Submissions: Supporting you with 510(k), PMA, or NDA submissions as appropriate.
• EMA and Other Regulatory Body Submissions: Ensuring compliance with EU regulations and other international standards.

After your product hits the market, we offer ongoing support to help you monitor product performance and compliance, including:

• FDA Submissions:Post-Market Studies: Assisting in the design and execution of post-market clinical follow-up studies.
• Risk Management Plans: Developing and implementing effective risk management strategies to address potential safety concerns.