WE ARE EXPERT REGULATORY ADVISORS SPECIALIZING IN MEDICAL DEVICE AND PHARMACEUTICALS ADHERENCE TO FDA REGULATIONS.
At HMG, we specialize in providing expert regulatory advice and ensuring adherence to FDA regulations.
Whether you need assistance with GMP readiness, NDA and ANDA applications, GS1/GUDID support, FDA registration and listing, 510K and pre-market approvals, ESG and ITACS account setups, internal and supplier audits, QMS development, equipment and facility validations, or additional services such as test method development, stability programs, risk management, and documentation templates, we’ve got you covered.
Let us navigate the regulatory landscape for you, so you can focus on what you do best. Contact us today at 833.464.2426 to experience the HMG difference.
Quality Management Solutions Services Include:
GMP READINESS
21CFR 820 – Quality System Regulations (Current Good Manufacturing practice requirements for Medical Devices)
21 CFR 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
A process where all the Medical devices and Pharmaceutical quality systems are audited to check for any gaps that could lead to non-conformances. HMG can help the firms with an audit and provide you with a gap analysis report and remediate any non-conformances that arise from the audit. FDA Pre-inspection evaluation, drafting FDA 483 responses and remediating any non-conformances that arise from the audit.
NDA & ANDA
NDA, New drug application is a regulatory pathway where the pharmaceutical manufacturer get approval for a new
drug for sale and marketing in US. ANDA, Abbreviated New Drug application is a regulatory pathway where the pharmaceutical manufacturer get approval for a generic drug for sale and marketing in US.
GS1/GUDID
GS1: GSI is an international organization that issues company prefixes and maintains its own standards for barcodes.
GUDID: GUDID stands for Global Unique Device Identification Database. It is a database administered by the FDA. This serves as a digital catalog for the FDA for every device that has the unique device identifier (UDI).
HMG can support the firm with:
- GS1 account Set-up
- Create and maintain GTINs database
- GUDID account Set-up
- GUDID database
FDA REGISTRATION & LISTING
HMG can support the firm with:
- The Initial FDA registration
- Annual registrations
- Device listings
- Initial Drug Establishments registration
- Annual Establishment registration and
- A US agent for effective communications with FDA
510K, PRE-MARKET APPROVALS, & DE NOVO
510K is known as Premarket Notification (PMN). 510K regulatory pathway where medical device manufacturers get a clearance from the FDA prior to marketing the device in the US market. Premarket Approval (PMA) application is a regulatory pathway where medical device manufacturer gets approval for a class III device.
De Novo request is a regulatory pathway where medical device manufacturer gets approval for novel medical devices.
HMG can provide:
- Regulatory guidance on Product codes,
- Regulatory guidance on choosing a predicate device,
- Review of the technical documentation prior to the submission,
- Drafting of protocols, Test methods and Work instructions,
- Prepare the submission for the 510K clearance,
- Guidance on how to use eSTAR and file the documents on the eSTAR template, and
- Guidance on How to submit the eSTAR through CDRH Portal
ESG Account Setup
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ITACS Account Setup
ITACS stands for Import Trade Auxiliary Communications System, which is used for tracking the shipment that will be imported into the USA. The system will allow you to upload all the shipping and regulatory documents that are needed for the imports. Documents submitted to FDA via ITACS get priority review over the documents submitted by fax or email.
Internal Audit
Internal Audit is an FDA requirement for medical devices and Pharmaceuticals manufacturers. HMG can support the firms by conducting annual internal audits and remediate any nonconformances that arise from the audit.
Supplier Audits
Internal Audit is an FDA requirement for medical devices and Pharmaceuticals manufacturers. HMG can support the firms by conducting annual internal audits and remediate any nonconformances that arise from the audit.
Build and Launch the QMS
QMS is a regulatory requirement for a manufacturer, Specification developer or a distributor. HMG can provide support in writing the procedures to launch the QMS and train the personnel to those procedures.
Equipment and Facility Validations
Equipment and Facility Validations are the FDA requirements for a manufacturer. HMG can provide support in writing the protocols, execution of the validations and write the reports and release the equipment for use in manufacturing.
Additional Services
Test method development and Test method validations
HMG can support developing a test method and validate those test methods prior to
using the method to test the finished drug product. Examples: Test methods on HPLC,UPLC, GC etc.
Stability Program
HMG can support in establishing a stability program, validations of stability chambers and validations of stability processes.
Risk Management
HMG can provide support in writing the Risk management files for the devices and drug products.
Design History file/ Master Formulation file, Device MasterRecords/Master Batch records and Device History record/Manufacturing Batch record templates
HMG can provide support in writing the Design History file/ Master Formulation file, Device Master Records/Master Batch records and Device History record/
Manufacturing Batch record templates for the devices and drug products.