About Us

Wonderfulland LLC is a comprehensive regulatory consulting firm that offers expertise across various critical areas of drug development. Our team comprises seasoned professionals, each with 20-30 years of functional experience in the pharmaceutical industry. Let’s delve into our core competencies:

  1. CMC (Chemistry, Manufacturing, and Controls): We meticulously oversee the quality, safety, and efficacy of pharmaceutical products by focusing on robust chemistry and manufacturing processes.
  2. Quality Assurance: Our commitment to maintaining high standards involves implementing rigorous quality systems, conducting audits, and ensuring compliance.
  3. Nonclinical Studies: We help you evaluating drug safety, pharmacology, and toxicology before advancing to human trials.
  4. Clinical Development: Our expertise spans the entire clinical trial lifecycle, from protocol design to data analysis, demonstrating drug efficacy and safety.
  5. Clinical Operations: We efficiently manage clinical trials through CRO, and perform safety surveillance.
  6. Regulatory Affairs: Navigating complex regulatory pathways is our forte. We excel in preparing submissions, including IND and NDA/BLA filings, while ensuring strict compliance with regulations.

Our successful track record in IND and NDA/BLA filings underscores our commitment to advancing drug development and contributing to global health. Partnering with us for unparalleled expertise and strategic guidance!

Our Services

Our services play a crucial role in bringing innovative therapies to patients while navigating complex regulatory landscapes.

Product Coverage

  • Small Molecule: chemicals, liposome, inhaled, lip nanoparticles,  small peptides, siRNAs, etc.
  • Monoclonal Antibodies (Mabs): monoclonal antibodies, Fc  fusion proteins, ADCs, bispecifics etc. novel or biosimilars.
  • Proteins and Peptides: insulins, cytokines, polypeptides etc.
  • mRNA Vaccines: in LNP or individual or through cell expression in vivo or ex vivo.
  • CART Products: Chimeric Antigen Receptor T-cell therapies for cancer treatment.
  • Gene Editing and Other Gene Therapy Products
  • Cell Products: Cellular therapies, such as stem cells or immune cells.

Regulatory Strategy Design

  • We provide comprehensive guidance on regulatory pathways, ensuring compliance with relevant regulations.
  • Tailored strategies for each product type, considering safety, efficacy, and market access.
  • Orphan drug designation application.
  • Fast track, breakthrough, and RMAT application.

FDA Meeting
Preparation and Leadership

  • Expertise in preparing meeting packages for interactions with the FDA. FDA EOP1, EOP2, pre-NDA and pre-BLA meeting preparation.
  • Lead meeting with FDA, EMA, MHRA and NMPA.

CMC (Chemistry, Manufacturing,
and Controls) Review and Design

  • Small Molecule: chemicals, liposome, inhaled, lip nanoparticles,  small peptides, siRNAs, etc.
  • Monoclonal Antibodies (Mabs): monoclonal antibodies, Fc  fusion proteins, ADCs, bispecifics etc. novel or biosimilars.
  • Proteins and Peptides: insulins, cytokines, polypeptides etc.
  • mRNA Vaccines: in LNP or individual or through cell expression in vivo or ex vivo.
  • CART Products: Chimeric Antigen Receptor T-cell therapies for cancer treatment.
  • Gene Editing and Other Gene Therapy Products
  • Cell Products: Cellular therapies, such as stem cells or immune cells.

Nonclinical Study
Design and Evaluation

  • Designing studies to assess safety and efficacy in preclinical models.
  • Protocol review, report evaluation, and submission package preparation.

Clinical Study Design
and Safety Surveillance

  • Expertise in preparing meeting packages for interactions with the FDA. FDA EOP1, EOP2, pre-NDA and pre-BLA meeting preparation.
  • Lead meeting with FDA, EMA, MHRA and China.
  • Writing the entire clinical protocol, IB, informed consent form, and general investigational plan.
  • SUSAR and DSUR reporting.
  • Pharmacovigilance consulting

Companion Diagnostic and Medical Device Consulting

  • Regulatory guidance for companion diagnostics (used alongside specific therapies).

GMP (Good Manufacturing Practice) compliance, QA and Process Validation:

  • Assessing manufacturing facilities for compliance with quality standards in US, EU and China.
  • Ensuring adherence to GMP principles for both small molecules and biologics.
  • Help the company to set up entire quality system including SOPs.
  • Function as the company’s QA to interact with CDMO and release products.
  • Process characterization and process validation study design and check.
  • Review of all the process characterization and validation reports.

Regulatory service

  • eCTD compiling and submission to the FDA
  • Annual product registration and reporting to the FDA
  • facility reporting to the FDA
  • IND maintenance to the FDA
  • IND, NDA and BLA filing to the FDA
  • Project management service

Why Choose Wonderfulland LLC

  • Founded by exFDA experts in March 2024 in Orlando, Florida, USA.
  • Most of the regulatory consultants in CMC, nonclinical and clinical have more than 20 years of experiences.
  • Span diseases in oncology, autoimmune disease, endocrinology, ophthalmology, cardiology, and neurology etc.
  • Products cover small molecule, specified biologics such as proteins, antibodies, ADCs, insulin, vaccines, cell and gene products.
  • Stage from preclinical design, CMC design to entire IND writing/review, to marketing application review/writing.
  • GMP compliance, pharmacovigilance, statistical and clinical pharmacology service at all stage of drug development.
  • Regulatory operation and US agent services.

Our Team

Audrey Jia

Audrey Jia

M.D., Ph.D., M.S.
  • More than 20 years of combined experience in biologic product development and the FDA CMC review.
  • Very experienced in IND and BLA review.
  • Very experienced in GMP mock inspections of biologics and small molecules.
  • Strong experience in US/China regulatory strategy.
  • Experienced in novel and biosimilar for Mab, Bispecific, ADC, cytokines, peptide, insulin, mRNA vaccines etc.
  • M.D., Peking University
  • Ph.D. in Biochemistry, Emory University
  • M.S. in Bioscience Regulatory Affairs, Johns Hopkins University
Xiaobiao Li, Ph.D

Xiaobiao Li, Ph.D

(EU Biologic CMC Expert)
  • 20+ years in top Pharma / CMO
  • Reg. CMC strategy / dossier (biological)
  • Global CTAs / MAAs
  • Life cycle management
  • 4 + years Reg. CMC Consultant
  • mAb/recombinant Protein, ADC Vaccine (Onco- & Covid19) Gene & Cell therapy
  • 16 Ph I / III CTAs
  • 2 Emergency use applications
  • 1 BLA
  • 3 CDE meetings
  • 1 DS/DP site transfer Life cycle management
John Liu

Lilia Bi

M.D., Ph.D.
  • More than 20 years of combined experience in clinical research and industry. Extensive experience interacting with FDA.
  • Leading clinical study design, preparation of synopsis, clinical protocol, ICF, IB, and other clinical modules for more than 40 INDs successfully filed to the FDA, involved in more than 70 IND submissions.
  • Leading Orphan Drug Designation applications for multiple diseases, initial Pediatric Study Plan preparation, and expedite drug development programs, such as fast track and breakthrough.
  • Involved in safety monitoring, AE adjudication, narratives writing and CSR preparation.
  • Experienced in biological, small molecule, mRNA, cellular and gene therapeutic products of oncology, vaccine, endocrinology disease, gastrointestinal disease, cardiopulmonary disease, autoimmune disease, ophthalmology, dermatology, kidney disease, infection disease, imaging and radiation medicine, and anesthesia, from phase I to III.
  • M.D./Ph.D. Tongji Medical school, Huazhong Science and Technology University, Wuhan, China
Ke Zhang

Keith Zhang

M.D.,Ph.D.
  • Almost 30 years of nonclinical review experiences in CDER, FDA.
  • Extensive experience in Pharmacology/Safety Pharmacology/ADME/Toxicology including:
  1. Gastroenterology
  2. Hepatology/NASH
  3. Rare Diseases
  4. Hematology
  5. Nutrition/dietary supplement/botanicals
  6. Cardiovascular safety pharmacology
  7. Safety assessment of impurities
  8. Safety assessment of leachable/extractables
  9. Safety assessment of drug metabolites
  10. Safety assessment of anti-sense drug
  11. PK/PD subcommittee
  • Ph.D. in Pharmacology, Ohio State University
  • M.S., China Medical University, Shenyang, China
  • M.D. Jin Zhou College of Medicine
Xu Wang

Xu Wang

M.D., Ph.D.
  • More than 30 years of medical experience in internal medicines including 16 years of FDA medical officer: Reviewed numerous NDAs, INDs, PINDs, Meeting Packages, Citizen’s Petitions, Consultations, Labels, and Safety Reports; Presented at AC and Industry/Sponsor Meetings. Specialized in Pulmonology, Allergy, Autoimmune and Critical Care.
  • MEDICAL LICENCURE
  •  State of Tennessee: Medicine and Surgery West Virginia Board of Medicine: Medicine and Surgery.
  • M.D. Sichuan Medical College, Chengdu, China (US ECFMG Certificate 2000)
  • PhD in Nutritional Science, Oregon State University, Corvallis, OR
  • Minors: Immunology, Molecular, and Cellular Biology
Yan Bai

Yan Bai

M.D., Ph.D.
  • More than 20 years experience in Pharmacoepidemology, Pharmacovigilance, and Clinical Development.  
  • Experience in RMP activities including Post-Marketing Requirements (PMR), Risk Evaluation and Mitigation Strategy (REMS) and Risk Minimization Measure (RMM) Evaluations;
  • Strong skills in epidemiology strategy, medical safety evaluation and understanding of US, China and global pharmacovigilance process
  • Extensive experience in cancer epidemiology and genetic epidemiology methods; application of genetic markers in drug safety studies
  • Experience with data mining methodology, signal detection and evaluation and risk analysis using internal and external data source (FDA AERS, Vigibase)
  • M.D., Peking University
  • Ph.D. in Epidemiology, Emory University

Contact us

  • audrey.jia@wonderfulland.net
  • 301-801-3271
  • WeChat: oceanland88