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Navigate Regulatory Complexities with Confidence
Why RegulatoryEdge?
Our Commitment to Excellence
When you partner with RegulatoryEdge, you gain a reliable and dedicated ally. We are committed to upholding the highest standards of integrity and professionalism in every project. We believe in the power of local expertise, which is why we attract and retain top talent right here in Australia. Unlike many consulting firms, we never outsource our activities offshore, ensuring your projects are handled with the utmost care, confidentiality, and attention to detail by our dedicated team. You can trust us to deliver exceptional results, on time and within budget.
What truly sets us apart is our unique expertise in the Australian regulatory landscape, our client-centric approach, and our comprehensive range of services designed to drive growth and ensure compliance. We proudly serve a diverse portfolio of past and current clients, including well-established Australian and international life science companies looking to expand their business or enter the Australian market. Their product range is equally varied, spanning Ethical Medicines (including small molecules, biologicals, and gene therapies), Over-the-Counter medicines, medical devices, and cosmetics.
Our Strengths
At RegulatoryEdge, our success is built on a foundation of key strengths:
- Superlative knowledge: We possess a deep and up-to-date understanding of regulatory requirements, and actively work to keep abreast of amendments and updates to policy and procedures.
- Exemplary leadership: Our principal Enisa employs strong leadership skills to set pathways, report progress and co-ordinate teams
- Consummate communication: We are able to conveys complex scientific research and data and relay regulatory requirements with ease and in different languages, ensuring clear understanding and effective collaboration.
- Ultimate resilience: Regulatory compliance is rarely straightforward or quick to achieve and requires mental stamina and the ability to constantly refresh and renew an approach
Meet Our Principal - Enisa Savic Hjelmaas
Enisa Savic Hjelmaas is commercially orientated pharmacologist with extensive experience in Scientific Affairs working across a number of various functions, product portfolios and therapeutic areas within the pharmaceutical industry. She is multilingual with international experience.
Key area of expertise include regulatory affairs consulting in area of regulatory development, submissions and commercialisation of products, critical review and analysis of manufacturing, toxicology and clinical data, and negotiation of win-win outcomes with regulatory authorities. Her expertise also extends to medical affairs and pharmacovigilance as well as skills such as project management, and leadership of cross functional initiatives with global scope, ultimately achieving greater business efficiencies and maximising commercial opportunities.
Enisa's LinkedIn profile is a testament to her industry reputation and expertise, featuring numerous endorsements* from colleagues and clients who attest to her skills, knowledge, and professionalism. These endorsements highlight her ability to deliver exceptional results, build strong relationships, and navigate complex regulatory challenges effectively. You can see these endorsements firsthand on her LinkedIn page.
On personal level Enisa is creative, strategic, efficient, and results-oriented problem solver with solid sense of business. She possesses persuasive negotiation skills and enjoys challenging environments, thriving as key member of achievement-oriented team.
*To view endorsements, you will need to log in your LinkedIn account prior to clicking on the link.
