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Welcome to Excel Regulatory Consulting.
Excel Regulatory Consulting was established in 1996.
Its principal, Dai-Shan Wong, has over 20
years of diversified experience in regulatory affairs. He has worked with
all the major products regulated by the FDA, including medical devices, biologics
and drugs. In addition, he is also an expert in the quality regulatory
compliance of manufacturing facilities, this includes establishing Good Manufacturing
Practices (GMP) and Quality System Regulations (QSR) systems and programs.
He has also prepared numerous clinical protocols. For a more detailed description
of services, please go to Services Description.
We provide cost effective services with personal attention.
We have also worked with many start-ups and new companies and are cognizant of the financial vigilance in starting a business.
Da-Shan Wong
President
Excel Regulatory Consulting
Excel Regulatory Consulting provides comprehensive, cost-effective, expert services to medical product companies working with Food and Drug Administration. We have experience with drugs, biologics and medical devices.
SERVICES
REGULATORY
FDA regulatory strategic planning
The most critical step in achieving success in regulatory process is early strategic planning. This involves:
Product classification
Regulatory pathway
Cost estimation
Timeline
FDA Liaison/negotiation/conference
Negotiating with FDA is a very important tool. We have extensive experience.
Resolution of deficiencies in FDA inspection
Resolution of FDA Warning Letter and Clinical Hold
FDA Submissions
A well-prepared submission ensures timely response and approval.
Investigational New Drug Application (IND)
Premarket Notification (510(k))
Investigational Device Exemption (IDE)
Premarket Approval (PMA)
CLINICAL
Clinical data are mandatory for drugs, biologics and certain devices. Clinical trials are time consuming and expensive. However, good planning and thorough trial management can avoid unnecessary delays and minimize unexpected expenses. Services include:
Clinical Protocol
Drafting, review and revision of clinical protocols including Phase I, Phase II and Phase III
Investigator recruiting, screening and selection
Clinical trial monitor
GCP Audit
Institutional Review Board documents
Informed Consent documentations
QUALITY SYSTEMS/
MANUFACTURING
By far the highest percent of FDA enforcement actions is due to deficiencies or violation of manufacturing and quality issues, i.e. Good Manufacturing Practices (GMP). Our expert services include:
Quality Systems/Programs
Good Manufacturing Practices (GMP) establishment and implementation
Quality System Regulations (QSR) establishment and implementation
Preparation of Quality Manual
Quality audits
Quality training
PRODUCT EXPERIENCE (partial list)
Medical Devices
Orthopedic devices
AIDS device
Cardiovascular software
Heart pump
Dental surgical device
Intrauterine incontinence device
Wound dressing
Dental implants
Clinical laboratory tests
Biologics
Autologous cell therapy
Interferons
Recombinant hormone
Gene therapy products
Drugs
Neurology
Immunology
Allergy
Multiple Sclerosis
AIDS
Cancer
Cardiology
Other Products
Dietary Supplements
NETWORK OF COLLABORATORS
Biostatisticians
Medical writers
IT consultants
Regulatory attorneys
PROFESSIONAL AFFILIATIONS
Regulatory Affairs Professional Society (RAPS)
Drug Information Association
Association for the Advancement of Medical Instrumentation
Licensing Executive Society, Texas
Texas Regulatory Affairs Association
BioHouston
Foreign Languages: Fluent in written and spoken Chinese, Cantonese and Mandarin.
PROFESSIONAL CERTIFICATION
Certified Regulatory Affairs Professional, Regulatory Affairs Professional Society
PRINCIPAL: Dai-Shan Wong
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