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Pharmaceutical Regulatory Consultants Services
Expert Regulatory Strategy and Submissions
We offer the wide range of consulting services to our clients such as:
Regulatory strategy for product development and commercialisation, where we advise how to address TGA requirements while maintaining compliance with the requirements of other competent authorities such as EMA, MHRA, FDA and Health Canada to name a few
Regulatory gap analysis and bridging dossier to meet TGA requirements
Registration of new product in Australia supported by body of data ranging from exclusively in-house trials, to abridged and fully Literature Based Submissions
Preparation of Australian specific Module 1 for medicines and compilation of CTD dossier
Product life cycle management
AI assisted or fully human medical writing of clinical and toxicology study reports, summaries and overviews for Modules 2-5
Preparation of Risk Management Plans including Australian specific annex.
Therapeutic Product Expertise
We are experts in the following types of therapeutic products:
Small molecules: simple chemical entities including antibiotics, over the counter medicines, vitamins, supplements and sunscreens
Biotech products: peptides, proteins, polysaccharides etc.
Biologicals: tissue-based products (skin, bone, ocular, cardiovascular, amnion), cell-based products (genetically modified, in vitro cell expansion or depletion), and faecal microbiota transplant
Medical device: any device that mainly works in a physical or mechanical way on the human body, including software
Cosmetics
This is not an exhaustive list of all products. If your product is not listed, we recommend reaching out to us for further assistance.
New Business Development
As regulatory consultants with commercial flare, we craft regulatory strategy that aligns with client’s business development goals. This involves:
Conducting a regulatory risk assessment to identify potential regulatory hurdles and develop mitigation strategies
Developing a regulatory roadmap that outlines the key regulatory milestones, timelines and costs for a new product or indication
Identifying regulatory dependencies and developing plans to address them, such as securing orphan drug designation or fast track approval
Based on our research and analysis of the regulatory dossier as well as other documentation and information in public domain about the competitors, we can recommend distinctive product positioning and strategy for a new product. This is often best executed by collaborating with marketing teams where ideas and expertise are shared to ensure regulatory risks are minimised and a path to market is successful.
We use our expertise to facilitate partnerships and collaborations with other companies, academia, or research institutions to bring new products or technologies to market. We can for example conduct regulatory due diligence on potential acquisitions, partnerships, or collaborations to ensure alignment with regulatory requirements and business goals.
Enhanced Medical Affairs Services
At RegulatoryEdge, we offer bespoke medical affairs consulting services, delivered in-house or remotely, to support the growth and compliance of pharmaceutical, biotech, and medical device companies in Australia.
Key services:
Medical Information Support: responding to simple and complex medical enquiries, including those needing summary of published literature, to ensure timely and accurate information for healthcare professionals and patients
Compliance with The Therapeutic Goods Advertising Code: reviewing promotional materials and labels to ensure compliance with relevant laws and regulations in Australia
Advertising Complaints and Corrective Actions: assisting clients with responding to advertising complaints and implementing corrective actions to maintain a strong regulatory posture
Process Optimisation: helping small-sized companies and those undergoing post-merger and acquisition integration to design and implement internal process and systems, to streamline the information flow, eliminate duplication, reduce resource demands and the potential for error.
Customised Drug Safety Services
We take a client-centric approach, and tailor our services to the unique needs and challenges of each organisation, for monitoring and reporting adverse events, product quality issues, and other post-market safety concerns in Australia.
Pharmacovigilance Management: Our team of local experts is dedicated to providing high-quality services when managing day-to-day pharmacovigilance activities, including case intake, follow up and reporting.
Mock Audits and Training Programs: We conduct periodic activities such as mock audits and training programs to prepare organisations for third party Drug Safety (Pharmacovigilance) audits and inspections.
New Subsidiary / Affiliate
We are proud to have assisted 3 clients with establishing their Australian affiliate/subsidiary from ground up.
We have worked with large US and Swedish pharmaceutical companies as well as smaller medical device company in establishing their presence in Australia.
We have assisted with company registrations with ASIC, agreements for product distribution with 3rd party suppliers and Regulatory Affairs registration of their products.
Start Up Company Infrastructure
We have proven track record for creating company infrastructure for our clients that meets requirements of Australian regulators and supports product distribution.
Some of our past clients had a support of their large mother companies overseas, and others were small family start up businesses.
No mater how big or small your company is, we are able to set up systems and processes for your organisation that will meet Regulatory Affairs requirements, pass Pharmacovigilance audit and support Medical Affairs. They will be tailored to your type of products.
Regulatory Affairs Coaching
We offer unique Regulatory Affairs coaching to selected clients who may be under increasing pressure to achieve commercial goals with their existing resources, or are looking for innovative approach to Regulatory Affairs management especially in light of emerging AI technologies.
We work very closely with our clients to truly transform their regulatory human capital and operations into an agile and modern function that serves the business growth and needs.