Whether you are part of an established team, a start-up, an SME, or a founder, navigating the stringent requirements of the Medical Technology, Biotechnology, and Pharmaceutical (MTP) sectors can be complex and challenging. This is where partnering with the right Regulatory Affairs Consultant becomes invaluable.
Understanding the Role of a Regulatory Affairs Consultant
A regulatory affairs consultant plays a crucial role in assisting SMEs and start-ups navigate the complex landscape of the Therapeutic Goods Administration (TGA), FDA, EMA and other regulatory agencies. In addition to acting as a regulatory affairs consultant for our clients, the Adjutor Healthcare group can assist you meet your global healthcare, development, regulatory and commercialisation needs.
Streamlining your development journey
We streamline your global development plans, ensuring expert guidance and advice at every stage, covering a range of services, including product and clinical development, dossier review-gap analysis, product registration (including literature-based submissions) and lifecycle management, quality/QMS, training and commercialisation. Our consultants have experience with all product classes, including prescription and non-prescription medicines, biologicals, cell and gene therapies, medical device technologies, and diagnostic tests, including IVDs.
Outlined below are the advantages that we bring to the table and commitments we make to our clients as a consultant and partner:
Assisting with your global healthcare development, regulatory and commercialisation strategy
The right strategy is essential in every step of the product lifecycle. From early development to mature market, a strategic approach can facilitate the speed to market and contribute to the reputation of your product and company. At the Adjutor Healthcare group, we help to build the right strategy from the beginning, ensuring that the requirements of the intended market(s) are met in a planned and coordinated manner, and can help avoid costly mistakes and delays.
Strategy without tactics is the slowest route to victory. Tactics without strategy is the noise before defeat.
Sun Tzu
Regulatory intelligence and insights to assist your decision making
As different markets have different laws and regulations, our regulatory affairs consultants stay on top of the global regulatory landscape and keep a close eye on the ever-changing nature of health authorities and their respective legislation, whether that be TGA, FDA, MHRA, EMA, NMPA, HSA, Swiss Medic, or other agency. The right strategic intelligence ensures that these requirements are met in a planned and coordinated manner with an eye on global requirements. The Adjutor Healthcare Group can help you navigate these requirements in the most time and cost-efficient manner without compromising safety, quality, or effectiveness outcomes.
The key is in not spending time, but in investing it.
Stephen R. Covey
A tried and tested record of product development and registration across the globe
As a startup or SME, time is your most valuable asset! Partnering with the Adjutor Healthcare Group offers a single point of entry to a trusted global network which is invaluable. This streamlined approach allows you to access critical resources, expertise, and opportunities without wasting precious time on trial and error or searching for multiple providers.
Headquartered in Australia, we leverage an extensive global network. Our lengthy and in-depth experience working across all major markets has given us a clear picture of what regulatory bodies are looking for, a sound understanding of how they approach different products, and the complexities that come with this.
— Adjutor Healthcare ©2024 —
40+
Years Experience
400
Medicines Registered
150
Medical Devices Registered
Our approach is tried and tested, built on proven strategies and experience that deliver real results. With over 40 years of experience in Global Healthcare Development, Regulatory and Commercialisation, and a proven track record of registering over 400 medicines & 150 medical devices worldwide, the Adjutor Healthcare Group is your trusted partner in achieving your global development objectives.
In seeking advice, find the one who challenges your thought process.
Anonymous
A compliance and quality-driven organisation
The breadth and depth of our regulatory affairs consultants’ experience provides a deep understanding of requirements across all types of applications. We are thorough and particular in preparing applications and work within a Quality Management System, resulting in efficient approvals from regulatory agencies. We provide strategic advice during the development program, preparing regulatory documents based on technical data, non-clinical and clinical data, acting as your regulatory agent and first point of contact with agencies. Our experience has also given us great insights into what evaluators expect to see, along with common deficiencies, so we can ensure that agency expectations are addressed.
Adjutor means Helper,
and that’s what we do.
Adjutor Healthcare
Finding a good fit for your team and project.
Our regulatory affairs consultants come from all corners of the industry, have extensive experience working with regulatory authorities, and are consistently networking with industry professionals and key opinion leaders. At the Adjutor Healthcare group, we establish meaningful connections that support the best outcomes for our stakeholders. We don’t just offer advice—we roll up our sleeves and get the work done as an extension of your team. Our approach is hands-on, taking the time to understand your business and its unique challenges and opportunities. We think of ourselves as a seamless part of your team, committed to helping you achieve your global healthcare development, regulatory and commercialisation goals.
The Adjutor Advantage
“The Adjutor Advantage is how we demonstrate, every day, that we are a great partner for your business. We’re engaged and motivated to help you at each stage of your journey to market and beyond.”
– Dr Rosalie Cull, Founder, The Adjutor Healthcare Group.
The Adjutor Advantage is a distinctive set of principles that underpin our commitment to excellence and client satisfaction. Our team is not just a service provider, we are your strategic partner, committed to helping you overcome challenges and achieve your objectives.
Responsive
We pride ourselves on responding quickly to our client’s needs, ensuring timely solutions and support whenever required.
Agile
In a rapidly changing business environment, our agile approach allows us to adapt quickly and efficiently to new challenges and opportunities.
Flexible
We understand that every client is unique, and we offer flexible solutions that can be customised to meet specific business goals and requirements.
Experts
Our team brings a wealth of knowledge and expertise across medicines and medical device development, providing insightful and strategic guidance.
Collaborative
We work closely with our clients, fostering a collaborative environment to achieve the best possible outcomes.
Reliable
Our clients can count on us for consistent, dependable service, and our commitment to supporting them reach their commercialisation goals.
Partnering with our consultants can be invaluable to your company due to our exceptional experience, connections, and understanding of the changing industry and regulatory environments in the Asia Pacific region, USA, Canada, UK, Europe and beyond.
Contact us for a confidential discussion and customised proposal for your next project and get the Adjutor Advantage working for you today!
Looking for the Right Regulatory Affairs Consultant for Your Business?
Contact us today and let’s work together to achieve your goals. Whether you have a question, need more information, or want to discuss your project, our team is here to help.
