added value with our Unique strategy consulting
- Tailored Support: We provide tailored strategy and efficient consulting and advisory support to meet your company needs as a small startup, a biotechnology firm, a large pharmaceutical company, or another life science research organization
- Team of one or many: From a single expert to a full team, our full or fractional support is customized to streamline your research and development process and accelerate the development and approval of your therapeutics.
- Broad range of diseases: We specialize in drug development in various diseases/clinical indications, ranging from more common to rare.
- Diverse drug modalities expertise: We cover diverse drug classes, including but not limited to small molecules, complex biologics (antibodies, enzymes, peptides), and cutting-edge treatments such as cell therapies (CAR-T, NK-cell), in-vivo gene and RNA, ADCs, and TLR-agonists therapies.
*Images were generated with the help of AI DALL.E and may not accurately represent the text descriptions or reflect the company.
What We Do
C-suite Consulting and Advisory
Our C-suite consultants have extensive biotechnology and pharmaceutical industry experience and a proven industry success record. They bring knowledge and expertise as interim or fractional Chief Medical Officers, Chief Development Officer, Other C-suite Senior Advisors, or Board members. They have successfully built and managed life science startups, secured funding, helped in corporate strategic shifts, directed clinical, regulatory, safety, and medical strategy, prepared operational frameworks for market entry, and held executive positions in private and public companies and developed complex biologics. *
Clinical Development and Medical Affairs Advisory and Consulting
Our advisors and working consultants will be part of your team. Their expertise ranges from Clinical Scientist, Medical Director (Medical Monitors) to VP of Clinical Development (High level strategy leadership and advice). We can help in authoring all needed clinical study documents from protocols to IND/NDA/BLA clinical sections. We can help at all stages of Phase 1-3 clinical trials and beyond. We can help you in your Medical Affairs endeavours, strategy consulting, operations consulting for any drug including complex biologics.*
Regulatory Consulting
Our regulatory consulting offers comprehensive assistance which encompasses developing regulatory strategies (small molecules and complex biologics), preparing IND submissions, and proficient preparation and management of BLA/NDA submissions. Additionally, we specialize in overseeing regulatory communications, which includes managing annual and routine reports such as DSUR, Investigator's Brochure (IB) updates, safety reporting, and more. We worked with FDA, EMA, Japan, Canada, China authorities*
Artificial Intelligence (AI) And Machine Learning (ML) Implementation
You have a great research idea only or ongoing clinical trial(s) then you need drug development strategy consulting. In order to succeed, you must differentiate yourself from competition and need to embrace the power of AI and machine learning. Choosing the best AI/ML platform and implementing it is getting harder and harder with so many companies offerings these days. We have access and work with various vendors utilizing AI/ML platforms and we will assess and match your need with operations consulting.*
Program Management Consulting
Our program management strategy consulting/ operations consulting services help your company improve its organizational structure and process, functional team efficiencies, leadership, and management practices. We work with you to identify areas of improvement, develop a customized plan, and implement change to optimize your business goals with a reduced budget and expedited timelines.*
Safety Risk (Medcal Monitoring and Pharmacovigilance) Consulting
Our patient safety risk operations consulting and management consulting services help you plan, identify, mitigate, and manage all safety risks (e.g. for your complex biologics) before and during the clinical trials, and after approval with experienced Medical Monitors and Medical Safety professionals who will provide unique strategy consulting . We work with you to develop a Medical Monitoring and Safety strategy.*
Talent Advice and Recruitment
Talent Transitioning to BioPharma
Talent Transitioning to BioPharma
Need to assess and plan for your resource requirements tailored to your clinical development phase and company needs? Looking to recruit top-tier talent full time for your team in addition to consulting? AXIAVITA offers to help you find full time professional talent for strategy and operations consulting to meet your needs.
Talent Transitioning to BioPharma
Talent Transitioning to BioPharma
Talent Transitioning to BioPharma
If you are a medical doctor or health care professional involved in patient care, who would like to have a better work-life balance and to transition to the biotechnology and pharmaceutical industry, we can provide training and advice and prepare you step-by-step to start your new career "on the right foot" for success in strategy consulting. *
Tax Advisors Access
Talent Transitioning to BioPharma
Tax Advisors Access
We have talented tax advisors (including international tax advice for foreign entities or companies conducting business outside the US), consultants, who can help you with your tax operations consulting and financial needs.*