Generics, Biosimilars & Combination Products

Accelerating Market Entry Through Scientific and Regulatory Excellence

Overview

The development and approval of generics, biosimilars, and drug–device combination products require a precise balance between regulatory compliance, scientific justification, and strategic positioning.
At North Pharma Consulting, we provide comprehensive regulatory and technical support for the preparation, evaluation, and submission of applications in these highly specialized categories.

Our experts guide clients through every stage — from bioequivalence planning and comparability studies to regulatory strategy and post-approval lifecycle management — ensuring that all requirements are met across EU, UK, CIS, MENA, LATAM, US, and Asia.

Key Challenges We Address

  • Complex and diverse requirements for generics and biosimilars in global markets
  • High data demands for comparability and interchangeability
  • Scientific justification for biowaivers and BE strategy design
  • Integration of device and drug regulatory pathways for combination products
  • Managing communication with multiple regulatory agencies

Our Approach

1. Generic Product Development & Regulatory Support

We assist clients in preparing abbreviated marketing authorisation applications (MAA) and optimizing their regulatory strategies for efficient approval.
This includes biowaiver justification, bioequivalence (BE) protocol design, and full CTD dossier support.

2. Biosimilar Development & Comparability Studies

Our team provides strategic guidance and documentation for biosimilar comparability covering quality, pharmacokinetics, pharmacodynamics, and immunogenicity.
We support you through scientific advice procedures, data gap assessments, and alignment with EMA, FDA, and WHO guidelines.

3. Drug–Device Combination Products

North Pharma Consulting helps define regulatory pathways for drug–device combination products, ensuring full compliance with both medicinal and device requirements.
We manage interface documentation, device master files, and risk assessments per MDR and relevant regulatory frameworks.

4. Bioequivalence & Biowaiver Strategy

We design BE study protocols and in vitro/in vivo correlation (IVIVC/IVIVR) models tailored to your formulation and therapeutic class.
Our specialists also prepare topical product testing strategies (IVRT/IVPT) and biowaiver justifications under BCS and ICH guidelines.

5. Global Submission & Lifecycle Coordination

From dossier authoring to post-approval variations, we ensure consistent regulatory communication and efficient submission management across target markets.

Benefits

  • Accelerated market access for generics and biosimilars
  • Robust scientific justification aligned with regulatory expectations
  • Minimized risk of agency queries and deficiencies
  • Efficient coordination for combination product approvals
  • End-to-end lifecycle support from development to post-approval

Why Choose North Pharma Consulting

With deep expertise in generic and biosimilar development, North Pharma Consulting combines scientific rigor with regulatory insight to deliver tailored strategies that shorten approval timelines and ensure compliance.
Our team’s multidisciplinary experience helps clients succeed in highly competitive therapeutic and technological landscapes.