BioTechLogic, Inc. assists companies by providing consultancy services that support the registration of drug-device combination products.
We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210/211), Biologics (21 CFR 600), Device (21 CFR 820) and Combination Products (21 CFR Part 4).
BioTechLogic’s team can guide you through the matrix of requirements by providing combination products consultancy services for the following:
- Design Control 483 observation trend
- Preparation and review of studies and requirements defined in FDA’s Draft Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
- Preparation of CTD regional sections (e.g., 3.2.R.4 Medical Device) that are founded on the Premarket Notification 510 (k) submission requirements and include information related to Summary Statements, Clinical Considerations, Design Features, Safety Related Features, Biocompatibility, Functional Performance Testing, Suitability and Human Factors Studies
- Preparation and review of functional performance testing protocols that follow ISO 7886-1:1993 (Single Use Syringes), ISO 10993-1:1997 (Medical Device, Evaluation and Testing), ISO 11608:200 (Pen-Injectors), ISO 21649:2006 (Needle-Free Injectors, Requirements and Test methods), ISO 594-2, ASTM D4169: 1999 (Performance Testing of Shipping Containers), ASTM F647 (Device Interaction with Drugs) standards, and FDA’s Draft Guidance for Glass Syringes for Delivering Drug and Biological Products
The following are examples of the services offered by BioTechLogic to help support combination products throughout product development and into commercialization.
- Provide advice on dossier approaches associated with US submissions
- Liaise with FDA
- Generate and review the Chemical, Manufacturing, and Controls (CMC) sections of regulatory submissions that support combination products (e.g., 3.2.P.2.4, 3.2.P.3.3, 3.2.P.7, and 3.2.R.4 – Medical Devices [Device Design Controls], etc.)
- Quality System Mapping and Quality Planning for products, gaps in the quality system, or transitions to new regulatory requirements
- Establish new quality management systems in accordance with Good Manufacturing Practices for Combination Products (21 CFR Part 4)
- Perform design control and design review gap assessments
- Provide on and off-site quality system support including reviewing documentation, generation of system procedures and forms, corrective and/or preventive action recommendations, management review system and training
Design Control Documentation
- Generate a Design and Development SOP or plan including templates for documentation of design inputs, design outputs, design reviews, and design verification
- Generate a Design History File SOP including a Design History File Index
- Support the generation of the following Design Control documents: User Requirements, Design Input, Design Output, and Design Verification Traceability Matrix, Design Verifications, and Design Validations (e.g. Process Validation, Stability and Human Factors Studies)
- Facilitate design reviews, act as an independent reviewer, and prepare design review documentation
- Facilitate the performance of a risk analysis (e.g. QRA FMEA) that identifies risk associated with the device design, its manufacturing process, and intended uses as required by 21 CFR 820.30(g)
- Generate a biocompatibility risk assessment
- Generate a CAPA SOP
- Generate an ISO compliant Purchasing Controls SOP
Combination Products Resources
In 2016 we released a paper, “4 Things You Need to Know About Combination Drug Compliance.” This paper is still entirely relevant today, and we encourage you to download it, but it was a fairly basic overview of the combination drug product regulatory landscape at a...
White Paper Navigating the European Union’s (EU) Drug Device Combination Product Regulatory ChangesThe European therapeutics market has been working to manage the upheaval caused by Brexit and is now working its way through yet another challenge: the medical devices...
From post-aging performance testing to container closure integrity, robust design controls extend far beyond “constituent part” requirements. With the increase in complexity of some combination products and co-packaged kits, the need remains for ensuring that the...
White Paper 4 Things You Need to Know About Combination Drug ComplianceCombination products are a fascinating area of the pharmaceutical industry and present great future promise. The segment is projected to reach $115 billion in global sales by the end of 2019. It...
Combination drug products are high on everyone’s radar screen, as seen in continuing discussion about appropriate testing and regulation of self-injectors, such as EpiPen, and emerging cellular and gene therapies. Manufacturers complain of delays in decisions by FDA’s...
Combination drug products are complex to both develop and to manage from a compliance perspective. This presentation discusses five critical areas of combination drug compliance including: What is 21 CFR Part 4? FDA’s Office of Combination Products Legacy Combination...