VCRO medical writing team is composed of 5 scientists covering wide range of medical and pharmaceutical areas with more than 5 decades of experience. All writers are with Doctoral degrees and are equipped with new drug development specialty from their academic/industrial background.
VCRO’s medical writers provide scientific and strategic service from preclinical toward clinical and ultimately to NDA. These services are delivered in a systemic, constructive and specific way to ensure successful outcomes.
VCRO medical writing team is highly experienced in wide spectrum of product types, from small molecule, botanical drug, biologics, cell therapy, medical device, live biotherapeutic product, combination product, and vaccine. The experienced area in filing US FDA IND includes oncology, neurology, infectious disease, dermatology, nuclear medicine, and gynecology. VCRO is proudly maintaining 100% US FDA IND clinical-go records. With VCRO’s ample experience and successful records, we are expanding quickly our medical writing service territory to Asia in order to offer a more spontaneous, no time-zone limitation, no culture difference, minimum language barrier, and customizable option to new drug development clients.
- Meeting with Health Authority
- US FDA Pre-IND Meeting
- US FDA End of Phase II Meeting
- US FDA Pre-NDA Meeting
- TFDA CDE consultation
- US FDA and TFDA Regulatory Consultation
- CMC and Preclinical Consultation
- ICH CTD Whole Package Writing and Compiling
- Gap Analysis for IND filing
- Response to Health Authorities Comments
- IND Maintenance and Annual Report
- Clinical Trial Document Preparation
- Clinical Protocol
- Investigators’ Brochure
- Clinical Study Report
- Data and Safety Monitoring Board Charter
- Safety Management Plan
- Bridging Study Evaluation
- Medical Monitoring