Medical Affairs
The Medical Affairs team serves as the core team of VCRO
Composed of PhDs and Master’s graduates in biotechnology, medicine, and pharmacy from renowned domestic and international universities, our team boasts extensive research and development experience in both academia and industry.
With 20+ years of success, our Medical Affairs team excels in pharmaceutical and medical device regulations in Taiwan, the US, and China. We support diverse products, from small molecule drugs to medical devices, with a commitment to innovation and customized solutions.
We tailor our advice to your specific needs, offering comprehensive support from preclinical to clinical stages and product licensure. We’ll guide you through research, development, and commercialization, helping you gain a competitive edge and achieve success.
What we can do
VCRO’s Medical Affairs team is committed to providing comprehensive regulatory consulting for product development, assisting you in overcoming development bottlenecks and formulating the optimal development strategy.
We prepare standardized technical documentation, tailor clinical trial designs to your objectives, and communicate with regulatory authorities to secure favorable approvals. During trials, we promptly monitor data to ensure accuracy and reliability.
Our expert team helps analyze, interpret, and present your research findings, empowering informed decisions for drug development and market access. We ensure your research meets scientific standards, regulatory requirements, and predefined objectives.
Development strategy consulting
From small molecule drugs and biologics to botanicals, cell therapies, gene therapies, medical devices, and combination products, we offer expert consulting services throughout various evaluation stages of your product’s development, including chemical manufacturing control, preclinical and clinical considerations.
Regulatory representative communication
Our experienced team communicates effectively with regulatory authorities, assisting in formal meetings (like Taiwan CDE consultations, US FDA pre-IND, INTERACT, etc.). We understand regulatory focus and product-specific issues, ensuring efficient communication and favorable decisions.
IND preparation and application
VCRO’s Medical Affairs team includes experts in clinical, non-clinical, regulatory affairs, and CMC. With deep scientific and regulatory expertise and a successful track record in US and Taiwan IND submissions, we strategically guide your drug’s clinical development journey.
Clinical trial planning
VCRO’s Medical Affairs team excels in developing diverse product types across all clinical trial phases and therapeutic areas including cancer, neurological disorders, immune diseases, cardiovascular diseases, infectious diseases, dermatological conditions, nuclear medicine, gynecological disorders, pain management, ophthalmology, and drug addiction. We excel in designing clinical study protocols that align with your objectives to ensure your clinical development plans.
Our medical affairs specialists craft precise technical documents for diverse healthcare products, following the ICH CTD format. This meets rigorous standards of major global regulatory authorities, including those in Taiwan, the US, EU, and China.
Regulations representative submission
VCRO boasts a team of seasoned regulatory experts equipped to provide you with the most accurate guidance and strategies for clinical trial applications or product registration, tailored from the perspective of regulatory authorities.
Beyond our technical expertise, we foster open and trusted communication with regulatory authorities to streamline the review process. We provide steadfast support throughout the submission process, ensuring accuracy at every stage of review.
What makes us special
- Leading the Way
For thirty years, VCRO’s clients have led new drug development in cutting-edge therapeutic areas. We closely monitor global medical and technological regulatory trends, collaborating with top institutions for innovative solutions.
- Care and companionship
We value your research project’s dedication and expectations, forging strong client partnerships. Our team deeply cares about your goals, offering relevant advice and comprehensive support at every stage, ready to tackle any challenges together.
- Stay professional
At VCRO’s Medical Affairs, our team of experienced experts ensures scientific rigor and regulatory compliance, continuously improving to exceed expectations.
- Embracing challenges
VCRO’s Medical Affairs department excels in tackling diverse challenges, embracing opportunities for growth with proactive and innovative strategies.
Our mission
We value commitments and efficiency, demanding timeliness and quality for every project.
We value our clients’ expectations and needs to ensure every project achieves its defined goals. Embracing a pioneering spirit and meticulous research, we remain steadfast in our belief that we can overcome any challenge and deliver outstanding outcomes for our clients.