H&A Clinical is a trusted partner for medical devices for everything from pre-market to post-market and all clinical research services in between.
CLINICAL RESEARCH ORGANISATION (CRO) SERVICES IN AUSTRALIA:
- Essential Documentation writeup: Clinical Investigation Protocol (CIP), Investigator Brochure (IB) per ISO 14155 or ICH GCP
- CRF and worksheet design
- Study close out
- Clinical field specialist support: clinical education and training, in-field support
- Regulatory & administrative support: HREC, RGO, CTN submissions
- Study monitoring and project management: SDV, SDR, safety reporting, study compliance
- Study oversight management: convening Investigator meetings, Data Safety/Monitoring Boards, KOL engagement
R&D - TECHNICAL & CLINICAL SERVICES
- Product design & development
- Prototyping and design for manufacture (DFM)
- Verification and validation (V&V)
- Production planning
- Risk management file (hazard analyses, design/user/process FMEAs)
- Clinical Evaluation Plan/Report (CEP/CER) writing
- Technical File development
- Manuscript writing/preparation for scientific journals
QUALITY MANAGEMENT & REGULATORY
- Regulatory & market access strategy (CE and TGA)
- QMS design and implementation (ISO 13485, 21 CFR 820)
- Regulatory submissions – conformity assessment (CE and TGA)
- Support for Notified Body/Competent Authority audits
- Post-market surveillance and regulatory reporting
BUSINESS CONSULTING
- Product commercialisation strategy
- Product launch strategy
- Device funding and commercialisation
- Technical training: GMP (ISO 13485), CGP (ICH-GCP and ISO 14155)
- Grant writing and application preparation
- Clinical and Engineering teams setup and mobilisation (Fractional COO or GM consulting)
Company Details
- Employees
- 2
- Founded
- -
- Address
- Sydney, Nsw, Au
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- https://www.haclinical.com/
- Keywords
- Clinical Trial Monitoring, Clinical Trial Management, ISO 13485, ISO 14155, Conformity Assessment, ISO 14971, Design & Development, Product Development, V&V, ICH-GCP, Source Data Verification, Clinical Evaluation Reports, Post-market Surveillance, MDR 2017/745, Quality Management Systems, CTMS, CAPA, Medical and clinical team management, medical device audits, Australian med device regulatory approval, biotech management, clinical trial design australia.
- HQ
- Sydney, NSW
H&a Clinical Questions
H&A Clinical's website is https://www.haclinical.com/
H&A Clinical's LinkedIn profile is https://au.linkedin.com/company/ha-clinical
H&A Clinical has
2 employees.
View email and phone details for 2
employees at H&A Clinical.
H&A Clinical's industry is
Medical Equipment Manufacturing
H&A Clinical's top competitors are
Quarry Management Services,
Jonkin Consulting Pty Ltd,
The Untapped Space,
Organicready,
Brisbane Hr,
Qms Electrical,
Global Edge Medtech Consulting,
Aethlon Medical, Inc.,
Qpro Australia Pty Ltd,
Logiqc Quality Management System.
H&A Clinical's categories are Medical Equipment Manufacturing
H&A Clinical's founding year is 2023
