About us:
Pharma Expert Australia Pty. Ltd. is an one stop solution centre for extensive range of pharmaceutical industry needs, widely operates in Australia, New Zealand and Asia. We thrive to bring the best outcome for clients by implementing the most effective strategies.
Clients’ trust means the most to us and our vision is to build trusted partner through our excellent service for pharmaceutical and biotech industry.
Our mission is to provide the best service to bring the affordable medicine to the valued customers.
Strategic Management and Planning:
Pharma Expert will assist you to perform a strategic analysis of your company to evaluate your current situation on the market, characterise the company and its mission, vision and goals. Afterwards, Pharma Expert will suggest for the suitable strategies and prepare the plan in order to improve company’s position on the market. Pharma Expert will work together to manage your strategy to achieve the organisation’s goals.
R&D Development and Product Portfolio Management:
Pharma Expert is highly capable to assist your real needs to empower your organisation to achieve your success through your R&D development and product portfolio management for global market. We have experience to develop R&D facility and train the team to develop new products for USA-FDA, EMEA, TGA and other markets. We deliver impact where it matters, from early drug development to commercialisation.
Laboratory Management:
Pharma Expert can optimise your laboratory management system to reduce the operational costs and increase the productivity. We have proven experience to establish Good Laboratory Practice (GLP) to support R&D and Quality Control. We can assist you to implement LIMS and 5S for your organisation.
Regulatory service, Product Life Cycle and Regulatory Strategy Management:
Pharma Expert has sound knowledge and extensive experience to develop and manage regulatory strategy to register the same product at the same time in USA, Europe, Australia, NZ and other regions. We provide service for NCE and ANDA filings and submission for New Drugs and Abbreviated Drug registration including Dossier Compilations, Variation Submission(Site Transfers and other types of variations), Change Control Management, Renewals, Regulatory Risk and GAP Analysis. Pharma expert will provide full range of regulatory supports to register your new product and maintain your existing product of your targeted markets.
Feasibility Studies and GAP analysis:
Pharma Expert will provide the feasibility study and GAP analysis to assist you to achieve your business target.
Project Management:
Pharma Expert has qualification and extensive experience to manage any kind of projects to meet our clients’ needs, including but not limited to Site/Facility Development, Product Development, Clinical Development and Clinical Project Management.
Quality, Compliance and GMP Management:
Our consultants can ensure your Quality System to meet the compliance and GMP requirements as per ICH, PIC/S, TGA, FDA, ISO 9001 and ISO 13485 for pharmaceutical manufacture. Pharma Expert will assist you to develop and implement your Quality Management System(QMS) across the company. If you are about to be audited by the TGA, FDA or any EU member states, or would like to be audited by any of them, then we can assist you to meet the GMP requirements. If you have already been audited, then we can help you to response and minimise the GMP audit findings. We provide GMP consulting services that are based on relevant, cost-effective and practical compliance.
Clinical and Bio-equivalency or Bio-Similarity management:
Pharma Expert has capacity and proven experience to manage Clinical Trials(Phase I-Phase IV) for new molecules and Bio-equivalency or Bio-similarity study management in Australia or in overseas in a cost effective way.
Computerise System, Equipment, Process, Method and Cleaning Validation:
Pharma Expert can assist you to design and develop all kinds of validation protocols and assist to perform the validation activities and ensure compliance with TGA or FDA or EMEA for all kind of validation requirements for your business.
Setting Pharma Business:
Pharma Expert has the extensive capability to setup your pharma business in Australia or in overseas through our business partners or networks and assist to manage your business through our excellent service to meet your business requirements.
Export/Import Drug Product and Drug Substances:
Pharma Expert is able to be your partner or find out the right partner to export or import your targeted product to meet your business targets.
Our team
Pharma Expert Australia Pty. Ltd. provides a resource of technical support personnel who are highly motivated to help you to meet your challenges. Our team members are knowledgeable with extensive experience in the pharmaceuticals industry and many of them have performed the same roles as some of your staff.
We put extra effort and emphasis on communication to understand your situation and needs, which help us to serve you in the most effective manner.
Our team members have hands on experience in all the wings of pharmaceuticals industry which have given them the ability to help to make the difference in your operation and could be a part to make your operation successful.
Our Experience:
We have extensive experience to work within the industry in Australia and outside of Australia, which put extra value to understand your business needs to reach your mission and vision.
Contact us:
General Enquiries: info@pharmaexpert.com.au
MELBOURNE (HEAD OFFICE):
70 Vaucluse Blvd.
Point Cook, VIC 3030
AUSTRALIA
Chief Executive Officer:
Hasan Naim
Phone: +61 0406107774
email: ceo@pharmaexpert.com.au