Regulatory and Quality Solutions

Experienced service providers of Regulatory and Quality solutions for Medical Devices, Pharmaceutical and Biological Products.

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Medical Devices

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Biological Products

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Device / Drug Combination Products

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Software as a Medical Device

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Prosthesis Reimbursement

Companies often come on a riddle when they intend to register their product in a region with higher ROI (return on investment) due to higher initial product registration process cost. At RQLogix we aim to assist our clients with optimum solutions to avoid regulatory submission pitfalls.

Most of the regulators / countries are accepting already registered products. These products are often low risk products and with increasing competition / low margin products. For higher classification and novel devices, the registration process require attention to detail and preparation, even these products are registered in overseas market. In the Australian market, they often get setback and face a lengthy registration process, if devices are selected for an application audit. Some class IIb devices and all class III devices require mandatory application audit.

Check our services section. This section is aimed to assist our clients to help understand Australian regulatory requirements

Our services are based on in-house highly knowledgeable professionals from the field of medical devices, pharmaceutical and biological sector.

We also pride our self in providing assistance to our clients with other regulatory avenues such as CE marking, EMA, US FDA, Health Canada and registration of products in New Zealand, Taiwan, Singapore, Japan and China.

Our Services

Click below Services to learn more....

Therapeutic Goods Inclusion on ARTG (Australian Therapeutic Goods Register) and New Zealand WAND (Web Assisted Notification Database)

At RQLogix, our dedicated staff gained valuable experience in registering medical devices, existing drugs and IND (investigational new drug), OTC (over the counter products) on the ARTG and New Zealand WAND.

Each therapeutic product has its own fingerprint and needs to be presented to unlock marketing potential. Depending on product, the registration process varies. For devices, the timeline is from 7 days to more than 12 months depending on product registration pathway. The IND applications may take longer than a year. Device-drug combination products are same as that of IND registration. The devices with software as a component vary upon risk associated with software and often registration timeline is in-line with medical devices.

Act as a Sponsor

We can act as your Australian Sponsor. As your Australian Sponsor, we will offer pre-market and post-market regulatory services.

ISO 13485 / ISO 9001

At RQLogix, we have dedicated staff who will provide you solutions related to developing, implementing, maintaining and monitoring your QMS compliance in conformance with ISO 13485:2016 / ISO 9001 standard. We can provide independent Internal Auditing services at minimal cost and value add to your existing QMS.

Conformity Assessment Compliance EU / TGA

Our in-house staff has more than 20 years of experience in establishing, managing and monitoring conformity assessment compliance that meets the Therapeutic Goods Medical Devices Regulations (TGA Australia) & EU MDD (revised EU MDR requirements). Companies often have their dedicated QA / RA staff to manage the conformity assessment compliance, however, in tricky situations (issuance of non-conformance) often the staff needs assistance. We routinely assist our clients to achieve and establish their product compliance that meets conformity assessment requirements / meet local regulations and applicable standards. Contact us for a confidential discussion, as we value the privacy and security of information. Once satisfied, we anticipate positive feedback that will give assurance to other clients about our service experience .

Clinical Evaluation / Clinical Evidence

The Australian regulations is similar to the EU requirements. However, TGA clinical evaluation requirements are significantly demanding then our EU counterparts. Recently we assisted one of our clients to register their novel product that were rejected three times by the TGA, we assisted this client to get their product registered via TGA panel 60 process. We help our clients with pre-submission preparation in order to avoid delay in product registration.

Medical Devices that have Software as a Component

With modern computing advancements, use of software in a medical device is an emerging necessity. Devices with electronic programming for the therapeutic purpose involve complexity in regulatory jargon. Most of the start-ups and existing companies invest a lot in R&D. However, few incorporate regulatory component during design and development (D&D) stage. Large device manufacturers and pharma now-a-days allocate these regulatory sources from conception. However, the smaller companies or start-ups struggle to allocate regulatory resources during D&D stage. At RQLogix, we can fit that gap and assist you with compliance and product registration.

US FDA has noted adverse event / product recalls since 1994 and their established standard published in the year 2002 is still a benchmark in the area of software validation for medical devices. Current standard IEC 62304 lists the harmonised standard for development and use of software as a medical device. The complexity associated with regulatory compliance can be collaboratively managed through RQLogix.

Device-Drug Combination Products

With novel technologies in drug delivery systems, it pays dividend to work on regulatory compliance simultaneously if you intend to register your IND (investigational new drug). Companies require significant amount of supporting data to satisfy regulatory assessor requirements to register drug-device combination products. By working closely with our clients based on the product compliance requirements, RQLogix staff will help register the product on ARTG (TGA) and WAND (Medsafe).

Product Realisation / Sterilisation

Most of the times, manufacturers focus on regulatory aspects of a product and miss on the basics of the product realisation steps such as sterilisation and packaging validation studies. RQLogix staff can assist you in developing appropriate sterilisation method (ethylene oxide- ETO, Gamma Irradiation, Steam Sterilisation). We can also prepare validation protocols in liaison with your preferred sterilisation service provider and execute the validation studies. This will assist you in developing routine sterilisation plan and planned dose audits / re-validations.

We will provide you detailed assistance in critical sterilisation aspects such as performing bio-burden testing (ISO 11737-1), sterility testing (IS0 11737-2/ USP/BP method), EO residual compliance (ISO 10993-7) etc.

Risk Benefit Analysis / Risk Management Report

We can help you develop, implement, maintain and monitor both process and product risk management in accordance with ISO 14971.

Prosthesis Reimbursement / Implanted Devices / Pharmaceutical Benefit Scheme

Prosthesis devices (surgically-implanted) and some pharmaceutical products are subsidised by the Australian Government. The process to bring your device under the Prosthesis list or under PBS can be set at the same time, while we apply your product on ARTG. This avenue is managed by our specialist staff by considering that the window to include on prosthesis list PBS scheme is very limited (products are only reviewed during the committee meeting, which is conducted at limited frequency in a year).

CE Marking

Even though we are geographically located outside the European zone, we can assist prospective customers to register their product in European Union. We will cater your applications to ensure your devices comply with CE marking requirements through EC compliance that meets the EU MDD requirements [Medical Device Regulations (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746)]. Contact us for further information / assistance.

Clinical Trials

Due to the increasing requirements of our clients, we have currently established our clinical trial services in liaison with Asia (India) based Clinical Trial service provider for medical devices and therapeutic drugs. Due to the complexity and higher cost to get clinical trial data conducted from Developed countries, we are focused to provide this low-cost value-added service to our Australian and overseas clients.

Apart from this, some countries (like China) now require clinical trials to be conducted in the selected geographical location for certain products (devices and drugs), and hence we are currently assessing our clinical trial service capabilities in other emerging countries like China. Please provide your interest via email, and we will update when we have this service available in other countries.

Supplier / Third Party Audit Services

We can conduct on-site supplier audits of the facility, perform supplier review and provide recommendations. Our charges are very competitive, so that you can utilise your human resources for other activities.

Advertising Review and Strategic Compliance

We have expertise to assist you in establishing advertisement that meet the TGA regulations.

Post Market Surveillance

Management of customer complaints, management of advisory notices, hazard alert and product recall.

IFU / Labels

Designing, Instructions for use and labels in compliance with applicable regulatory requirements

Preparation of Design Dossier / Technical File

Biological Evaluation of Devices in compliance with ISO 10993

Appraisal of Clinical Evaluation / Clinical Evidence

Internal Auditing

Supplier qualification and Monitoring

Packaging studies (setting shelf life)

We can also take responsibility to conduct biological evaluation studies at economical rate from accredited facilities (ISO 17025)

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