About

Who we are

DWC Pharmaceutical consulting (DWC) is a new domestic and international consulting firm of comprised services, provided by former industry experts with production, audit and drug development experience. The company relies on know-how of each individual and forms an extensive internal and external network.

DWC is deeply rooted with an appreciation for regulatory compliance. This fundamental hand-on know-how with industry expertise ensure that pragmatic and practical solutions are proposed to customers and clients.

DWC provides regulatory cGMP and clinical support required to successfully support both innovative and generic, predominantly but not exclusively, small molecule products to the market, including regulatory inspection preparation, as well as supporting the customer's regulatory needs. 

DWC provides experience in supporting all phases of clinical and commercial production with a special emphasis on the japanese regulatory environment, economic aspects and cultural differences. This is particularly expressed in the section "Japan Development Program".

Senior associates with vast working knowledge and project management capabilities can support companies with respect to staffing of key quality assurance and regulatory affairs functions.

DWC continues to support all types of regulatory activities or audit (Due Diligences) needs (e.g., GLP, GCP and GMP). In addition, DWC has extensive experience in various regions such as USA, Europe, Japan, Middle East, India, China, South Korea and Taiwan.

 

Executive Director
Dror Wohlfeiler, Ph.D.



 

A pharmaceutical professional with over than 28 years of experience, in the EU, US, Israel, Japan and other asian countries; on site, regional and corporate roles.

Until 2007 headed the quality control laboratories for Teva’s Israeli operation division, responsible for realeasing finished product shippments of over than 4 B $ in 2006, and involved in couple of the biggest generic launches in the history (Pravastatin, Simvastatin and Setraline Tablets).

From 2007 onwards supervised teams in branded and generic R&D of global project teams for Phase I to III drug developments, resulting in more than 100 approved ANDA submissions, 1 NDA and numerous Phase 3 trials in Japan.

As a team member established a joint venture (JV) entity, Teva-Kowa, with a company in Japan, and localy managed the R&D operation in addition to a board membership. In this function the R&D product development sites, were located in 5 diffrent territories, for the ANDA’s submissions and approvals in Japan.

Before joining Teva pharmaceuticals working for Taro Pharmaceuticals (part of Sun Pharmaceuticals) and other mid-sized companies in diverse roles throughout research, production, quality control and assurance.

Since 2017 involved as a freelance with various global pharmaceutical companies, mostly in Europe, in different consultancy projects, such as FDA compliance readiness, due diligences and lab management, to overseeing an analytical technology transfer of an API production for a Chinese CMO’s, and education and supporting companies about the requirements for entering the japanese pharmaceutical market.

In addition freelance activities in fields of quality, compliance and Due diligences audits for healthcare cooperation (Lachman Consultants Inc. and Validant).

Key competencies in :

  • Clinical and CMC drug development.
  • Japanese regulatory requirements. 
  •  Product/process experience across API’s, OSD, Sterile and Biologics 
  • Expertise in cGMP, Quality Assurance and Control, Compliance, OOS Investigations 
  • Quality control laboratory operations and quality systems
  • Analytical method development and validation
  • Product Remediation Plans
  • FDA/EMA/PMDA inspection management, Data Integrity, Auditing/Due Diligence.

 

 


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