Plus Daily Services
- Manufacturing Setup
- Private Label supply
- Regulatory Consultant
- TGA Sponsorship
- Product Registration Services
1. Setting Up A Pharmaceutical Manufacturing
Initial Development of
Manufacturing Plans
Designing the manufacturing
process to ensure consistency
and reliability of production based on GMP.
Build New Facility
or Expand Capacity
Building a new facility or
expanding an existing
facility.
Manufacturing Scale Up
Process
Building quality into the
manufacturing process is a
key focus in product and
process design, including
scaling up production
GMP Submission and Inspections
Ensuring manufacturing complies with GMP, PIC and other regulatory requiremnts.
2. Private Label Supply
GMP MANUFACTURING & SUPPLY
Our FDA and TGA approved manufacturing partners will ensure production meets your regulatory and GMP requirements. Our global industry partners can help you bring more formulations to market faster.
Research & Development
We offer full-service capabilities across the entire life cycle of our products. We offer access to a comprehensive continuum of services ranging from discovery support to launch. Coordinated project management from the clinical stage to commercialisation and full regulatory affairs assistance, including regulatory agency liaison, preparation of expert reports and compilation of dossiers.
Regulatory approval
We can also provide continuous supply to your brand thanks to our unique technologies, extensive expertise, and proven track record of regulatory and commercialisation success.
Call us today to discuss your project
1300 89 89 58
Phone: 09:00 - 16:00
M-F
3. TGA Regulatory Consultant
Our expert staff and associates can help you launch your brand in Australia, including ARTG listing services.
For the purposes of listing on the ARTG (Australia Register of Therapeutics Goods), each product must have a sponsor.
The sponsor is responsible for applying to the TGA to have therapeutic goods listed on the Australian Register of Therapeutic Goods (ARTG). In Australia, therapeutic goods must be included on the ARTG before they can be sold. The sponsor must be a resident of Australia or be an incorporated body in Australia, and conducting business in Australia, where the representative of the company is residing in Australia.
Plus Daily can assist or act as the sponsor for your brand. Plus Daily would offer the following services:
Expert inspection of each product, including: ingredients, claims, and labelling, prior to applying for inclusion in the Australian Register of Therapeutic Goods (ARTG).
- Manufacturing process review
- Risk management plan, analysis, and report
- Instructions for use and labelling
- Packaging
- Stability data
- Analytical and clinical performance data
- Australian telephone helpline
- Website
- TGA compliance with advertising
- Provide the records to the Secretary (TGA) on request.
- Review of the post-market obligations:
i) adverse events and reports
ii) Stability/ shelf-life studies and reports
iii) Advertising and marketing compliance with code
iv) Pharmacovigilance
- Prepare and file application for inclusion in the ARTG
- GMP Agreement
- Approved ingredients and applications for new ingredients if required
- Claims
- Label and Packaging
- Supporting documents
- Comply with the Sponsor's and Manufacturer's ongoing responsibilities
- Conduct Stability/ shelf-life studies and report Post market reviews
- Pharmacovigilance:
• SOP Suspected Adverse Reactions
• SOP Significant safety issues
• SOP Handling Product Complaints
• SOP Recall coordinators
- PRODUCT LINE EVALUATION FOR DISTRIBUTION
Consultation & recommendations from our top-level industry professionals.
- STRATEGIC ACTION PLAN FOR DISTRIBUTION AND MARKETING
Strategic analysis of distribution channels and their required inhouse marketing plans.
- COMPETITIVE ANALYSIS
- CUSTOMS & FREIGHT
Transport and importation through Australian customs and to our warehouse facility, Target account and retailer.
- ASSOCIATE TRAINING AND SALE FORCE
Product education and training for our staff, external sales force and any associated accounts.
5.1. REGULATORY AFFAIRS ACTIVITIES
Maintain and report all TGA requirements and obligations as the sponsor of the product.
5.2. COMMUNICATION & REPORTING WITH BUYERS AND CLIENT
Ongoing communication with Client and buyers regarding sales and distribution.
5.3. ADMINISTRATIVE SERVICES
In-house administrative & accounting services regarding retail accounts.
5.4. ORDER ENTRY & PROCESSING
Processing and fulfillment of purchase orders from retail accounts via inventory.
WAREHOUSING
State-of-the-art, secure storage of inventory of products for rapid order fulfilment.
5.6. VENDOR SETUPS
Agreements, contracts, shipping & setup completion with all vendors and retailers.
5.7. EDI SERVICES
Electronic Data Interchange services for secure transmission of vital documents.
5.8. INVOICING ACCOUNTS
Timely invoicing of retail accounts to ensure prompt payment.
5.9. LOGISTICS
Ongoing logistical support for shipping, delivery, and national distribution.
1. DIGITAL AUDIT
Professional evaluation and critique of existing web presence by our digital media experts. Recommendations for expansion, improvement, and forward momentum.
2. NEWSLETTER, PUBLIC RELATIONS, TEXT MESSAGE UPDATES
Initial public relations campaign, email newsletter or text message updates setup. Includes development of future PR strategy.
3. GOOGLE ADS / PPC
Set up of initial Pay Per Click advertising campaign on Google Ads, including keyword targeting, ad analytics integration and progress reports.
4. WEBSITE CREATION & MANAGEMENT
Responsive sites, mobile optimization, etc.
5. SOCIAL MEDIA MANAGEMENT
Facebook, Twitter, Yelp, Instagram, LinkedIn, Pinterest, etc.
6. PHOTOGRAPHY & VIDEOGRAPHY
Product & location.
7. GOOGLE ACCOUNT OPTIMIZATION
Google My Business, Analytics, Google WebMaster etc.
8. REPUTATION MANAGEMENT
Online review, surveillance, and individual responses.
9. SHOPPING CART
Online sales setup.
10. LANDING PAGES
Local Web page promoting product for specific region.
11. PUBLIC RELATIONS
Promotions and upcoming events.
- NITIAL SETUP FEE
- ACCOUNT MANAGEMENT MONTHLY FEE
- MARKETING
Please contact us for a free no obligation quote
We specialise in regulations of high demand products like Rapid Antigen Test (RAT), Disinfectants, Hand Sanitisers, PPE Wear (face masks, gloves, gowns etc.) and other medical need speciality products. We can assist with the complete package from testing through to registration.
4. TGA Sponsorship
TGA Registration
We can assist with your product registration with the TGA. Our TGA consultants will guide you through the process and costs involved. We specialise in complementary medicines, listed medicines, over the counter medicines and medical devices regulations within the TGA.
Medical Devices
The TGA requires that all medical devices and IVDs sold in Australia be included on the ARTG. We can assist with relevant product review, device classification and finally, device registration with the TGA.
We can assist with ISO 13485 compliance for Medical Devices.
Product Development
Based on your objectives we can help to launch a product, Starting from formulation, GMP manufacturing, packaging, clinical data, technical documentation and full regulatory compliance. we can look after all pre and post market activities for your products in the market.
Quality Management System
We offer full Quality Management System (QMS) pertaining to ISO standards, TGA Pic/s and APVMA GMP.
We oversee and run stability program, validations, risk management. risk assessments and pharmacovigilance
5. Aust L Product Registration Services