About Complya Consulting

Complya Asia, Shanghai, China

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Complya AsiaComplya Asia is a consulting company registered in China with headquarters in Suzhou (near Shanghai). We provide consulting services to life sciences companies in the area of Quality Assurance and cGMP compliance. Our founders have an average of more than 20 years’ experience in pharmaceutical and medical device QA and cGMP operations. We have worked with numerous international and domestic companies throughout the US, Europe, and Asia who are developing therapeutic, vaccine, diagnostic and medical device products.

Complya Asia provides expertise and guidance to help pharmaceutical, biotechnology and medical device companies meet international cGMP compliance requirements. Working with your in-house experts, our Quality Assurance specialists will ensure your Quality Systems and facilities meet the current standards for US FDA, European EMA, and other international organizations.

Complya Asia services include:

Gap Analysis

Evaluation of your facility, documentation and operations to identify areas of risk with respect to regulatory requirements.

Inspection Readiness

Our experts have been through many EMA and FDA inspections; we can assist you in preparing for inspections by regulatory authorities, by clients, and by partners; we can also perform mock inspections.

Vendor Audits

We can ensure that your suppliers meet your requirements and those of regulatory agencies.

CMC (Chemistry, Manufacturing and Controls)

We have experience in preparation of INDs, NDAs and BLAs. We can manage your contract manufacturing and testing organizations.

Operations Support and Improvement

Our trained specialists can supplement your in-house staff when you face special needs, including reviewing batch records, reviewing validation protocols and reports, providing technical translation of documents, or serving as QA person-in-the-plant during operations.

Facility Review

Our experience in the design and construction of cGMP facilities can assist you in avoiding compliance issues during later inspections.

Training

Our experienced specialists can provide specialized and general training in Quality Systems, documentation, cGMP operations, and inspections or audits.

Scott M. Wheelwright, PhD: Cofounder and Principal Consultant

Scott M. Wheelwright, PhD

Cofounder and Principal Consultant

Scott M. Wheelwright, PhD, is cofounder, principal consultant and president of Complya Asia. He works with many types of pharmaceutical and life science companies to help them meet international standards for quality.

Dr. Wheelwright has technical expertise in yeast and bacterial fermentation, cell culture, monoclonal antibodies, proteins and viruses. He has directly participated in developing oncology, infectious disease, cardiovascular, wound healing, angiogenesis, vaccine and diagnostic products. Dr. Wheelwright has 30 years’ experience in solving the challenges companies encounter when bringing biotechnology and other medical products out of research and into the commercial marketplace.

Dr. Wheelwright is also founder and president of Strategic Manufacturing Worldwide, Inc. (SMW), a consulting firm that supports cGMP compliance in manufacturing operations and Quality Assurance. SMW provides business and technical expertise to biotechnology and related industries in the areas of operations management, manufacturing outsourcing, CMC development activities and facility design. Previously, Dr. Wheelwright served as the founding COO for Innovent, a biopharmaceutical company in China developing monoclonal antibody products for sale in China and worldwide. Innovent has designed a large-scale cGMP manufacturing plant for cell culture exceeding 70,000 L in capacity.

Dr. Wheelwright has been an executive officer in several biotech start-ups, and has supervised the areas of manufacturing, process development, compliance, Quality Assurance, Quality Control, validation, engineering and facilities. He has worked as a researcher in the laboratory and has led the development of several products that are now on the market. Dr. Wheelwright has also led the construction of multiple manufacturing facilities that meet the compliance requirements for cGMP. His corporate experience includes Abbott, Chiron (now Novartis) and Scios (now Johnson & Johnson).

Dr. Wheelwright obtained his PhD degree in chemical engineering from the University of California at Berkeley and his B.S. degree in chemical engineering from the University of Utah. He performed post-doctoral studies in biophysics at the Max Planck Institute in Germany. He is the author of a book on protein purification and has published many papers on process design, manufacturing, and compliance for pharmaceuticals and biologics.