Combination Product Regulatory Affairs Services - Overview
Combination products, a burgeoning sector in the Biopharmaceutical industry, encompass a diverse range of products with two or more components, which will be Pharmaceutical/Biological drugs and medical devices, in a combination of drug-drug or drug-device to enhance efficacy and deliver the necessary benefit to the patient. The necessity for combination products availability for patients and also the market for combination products is experiencing significant growth. This growth is projected to reach $139,193 million by 2025 at a CAGR of 6.9%.
Types of Combination Products:
1. Single-Entity Combination Products:
These products involve the physical, chemical, or other forms of combination to produce a unified entity. Examples include prefilled syringes, transdermal patches, and drug-eluting stents.
2. Co-Packaged Combination Products:
This category involves packaging two or more separate products in a single package or unit. Products such as surgical or first-aid kits fall into this classification.
3. Cross-Labeled Combination Products:
In this type, a drug/biological, or device product is packaged separately but intended for use only with another specifically approved product. Both components are indispensable to achieve the intended use, indication, or desired therapeutic effect.
The regulatory requirements for combination products are based on the primary mode of action (PMOA) of the combination. The regulatory requirements for combination products may combine elements from the separate statutory and regulatory requirements applicable to Pharmaceutical/Biological products and devices.
Registering combination products with respective Health Authorities demands a customized approach that includes close consultation with the relevant Health Agencies for approval.
A regulatory partnership can enable a hassle-free approach toward product registration, approval, and market entry. Freyr, a leading regulatory service provider with expertise in handling all types of combination products in handling end-to-end registration activities can support you through the registration process with our customized approach, customized to your product's specific requirements to facilitate smooth and efficient regulatory approvals worldwide.
Combination Product Regulatory Affairs Services
- Regulatory and market intelligence services.
- Health Authority Interactions.
- Comprehensive Regulatory roadmap and strategic guidance for combination products. Regulatory strategic guidance during product development with a quality-by-design (QBD) approach.
- Regulatory gap analysis, and guidance for gaps remediation.
- Authoring CTD Modules for Combination products registration with First Time Right Approach.
- Strategic guidance on Clinical and Non-Clinical development plans and activities.
- Regulatory labeling and technical writing services.
- Document and labeling translation services.
- Health Agency Interactions and Correspondence service.
- Regulatory artwork services.
- Pharmacovigilance and PMS services.
- Publishing services.
- Strategy and Response to Health Authority Queries.
- Change Controls assessment, Strategy and preparation of post-approval submissions and Life Cycle Management.
- Comprehensive customized regulatory submission strategy
- One-stop solution for all regulatory activities for End-to-End registration of Combination Products
- Thorough regulatory assessment of all source documents/data and guidance for mitigation
- Authoring of CTD Modules with the First Time Right Approach
- On-time completion of submissions
- Pool of experts with real time experience to handle all dosage forms/product categories.
- Local/Legal representation capabilities
- Expertise in drug development and regulatory support till the product in the Market.
