Product and Process Transition Support
West RA can provide customers with regulatory assessments to identify potential regulatory risks, suggest mitigation strategies, and provide references to relevant guidances for support. West regulatory assessment documents can provide customers with the tools needed to help build an overall regulatory submission strategy and facilitate the transition.
Global Compliance Certifications
Regulatory Affairs provides customers with Regulatory Compliance Certificates to verify that West products and processes meet regulatory agency expectations in all major markets.
Examples of compliance certification letters include:
- Direct/Indirect Food Contact Regulations
- Materials of Animal Origin (TSE/BSE Risk Evaluation for Raw Materials)
- Heavy Metals (Toxics in Packaging Legislation)
- Natural Rubber Latex/Dry Natural Rubber Content
- Additives of Concern (phthalates, nitrosamines, etc.)
- Elemental Impurities
- Conflict Minerals
Drug Master Files
West maintains an extensive portfolio of Drug Master Files (DMFs), Master Access Files (MAFs), 510ks and Canadian Licenses with both the FDA and Health Canada. Some of our DMFs are acknowledged to be the most heavily accessed DMFs at either agency. Upon request, West can provide Letters of Authorization/Access (LOAs) to customers for inclusion in their drug applications.
Each year, West provides over 1800 LOAs to its DMFs, using a convenient online request form. West RA has worked with both FDA and Health Canada to define industry standards for conversion of packaging and process DMFs to electronic format (eCTD). The entire West DMF portfolio has been converted to eCTD, so that files are compliant with FDA and Health Canada requirements for electronic DMFs.
The DMF portfolio includes the following West products and processes:
- Contract laboratory test methods
- Daikyo Crystal Zenith® vials
- Daikyo Crystal Zenith cartridge systems
- Daikyo Crystal Zenith syringe system
- Elastomer formulations, films and coatings
- NovaPure® components
- Steam sterilization process
- Westar® Ready-to-Sterilize (RS) wash process
- Westar (RS) washed lined seals
- Westar® Ready-to-Use (RU) steam sterilization
- Westar RU gamma sterilization
- SelfDose® Manual-Injector System
- SmartDose® Platform
Global Submission Support Packages
Global Submission Support Packages are intended to support customers in countries where Drug Master Files (DMFs) and Master Access Files (MAFs) have not been established. They provide customers with the technical information for West products and processes needed for inclusion in their drug applications.The content of each package is designed to meet Health Authority expectations for pharmaceutical components and delivery systems in drug applications and they are backed by West RA support for any follow-up questions you may receive from reviewing agencies. West currently has or can provide packages for the following products and processes:
- Daikyo Crystal Zenith Cartridge System
- Daikyo Crystal Zenith Syringe System
- Daikyo Crystal Zenith Vials
- NovaPure RS/RU
- Steam Sterilization Process
- Standard Elastomers
- Westar RS Lined Seals
- Westar RS Wash Process
- Westar RU Gamma Sterilization Process
- Westar RU Steam Sterilization process
- SelfDose Manual Injector
- SmartDose Platform
Global Agency Response Documents
When a drug application is being reviewed by a health authority (HA), follow-up questions may be posed and could involve a West component. Regulatory Affairs provides customers with high-quality support for any HA questions regarding West products and processes. West provides the necessary information for inclusion in a response document or can provide responses directly to the relevant agency.
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019.
The US Food and Drug Administration (FDA) recently issued a draft guidance: Comparative analyses and related comparative use human factor studies for a drug-device combination product submitted in an ANDA, January 2017. This guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product, that include a drug and a delivery device intended to administer a drug product.
The EU Commission welcomes the adoption of two new medical devices regulations which establish a modernized and more robust EU legislative framework to ensure better protection of public health and patient safety. The new rules will only apply after a transitional period. Three years after entry into force for the Regulation on medical devices (spring 2020) and five years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
This final rule is founded on the postmarketing safety reporting regulatory scheme associated with the application under which the combination product received marketing authorization, plus any applicable requirements associated with the constituent part(s).
Abstract: GDUFA II becomes effective on October 1, 2017, bringing significant changes to the user fee structure. Some of these changes may provide incentives for generic drug manufacturers to pursue manufacturing upgrades that may have previously been prohibitive.
Abstract: European medical device licensing regulations permit Notified Bodies to evaluate manufacturers and suppliers for conformance to quality standards. Suppliers identified as critical may be subject to announced and unannounced audits and must comply or risk jeopardizing the device manufacturer’s license.
Abstract: Human factors studies plays a key role in maximizing the likelihood that the device will be safe and effective for use by the intended users and environments.