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
Lilia Bi

Lilia Bi

M.D., Ph.D.
  • CMC expert for Cell and Gene Therapy, Ex FDA master CMC reviewer for CGT products
  • 21 years of FDA CMC review experience for cell and gene therapy product.
  • Highly experienced in pre-IND, IND, BLA, Post-approval submissions, and Master Files at all product development stages
  • She was the review committee Chair for the first AAV BLA approved by FDA
  • Participated in developing multiple regulatory policy and guidance for gene therapies
  • MD: Peking Union Medical College
  • PhD: The Johns Hopkins University
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