About Us

NDA CONSULTANTS

Nick Davies & Associates LLC (NDA) is an International Pharmaceutical and Biotech Consulting organization founded by Nick Davies, a dynamic leader who delivers results by developing and implementing bold strategic solutions to address complex business issues.

Depending on the nature and location of an assignment NDA establishes a team of Pharmaceutical and Biotech Manufacturing expertise drawn from our global team of consultants.

Details on some of our consultants are described below

NICK DAVIES

NICK DAVIES providing 25+ years of results and experience with GlaxoSmithKline and The International Partnership for Microbicides.

Nick’s expertise lies in manufacturing strategy and rationalization, global supply chain start-ups, complex global change program leadership, multi-million dollar project management, change management and clinical supplies.

Accomplished in starting up new manufacturing facilities, rationalizing global manufacturing operations, reengineering global manufacturing organizations, managing the sale of manufacturing facilities, directing manufacturing site closures and product divestments, and new product introduction and launches. Successful in developing business cases, winning approval for multi-million dollar investment projects, turning around multi-million dollar stock outs and supply shortages issues, and creating effective strategies to combat illegal product trade activities.

Nick has lived and worked in 5 different countries (UK, Thailand, South Korea, USA, and Canada). Conducted business in more than 26 countries including China, India, Thailand, Malaysia, Indonesia, Taiwan, Pakistan, Japan, Korea, Singapore, Australia, Kenya, UK, Ireland, France, Germany, Italy, Spain, Norway, Sweden, Turkey, Brazil, Argentina, and Venezuela.

He travels globally to establish new supply chain organizations, selling manufacturing plants, auditing manufacturing facilities, and managing multi-million dollar projects and programs.

He has partnered with Senior Executives on major corporate activities such as Mergers & Acquisitions, corporate turnarounds, joint venture start-ups, and corporate reorganizations.

GUY HEWES

GUY HEWES specializes in working with executives globally to help them deliver sustainable business improvement.

Guy is a recognized expert in enhancing the performance of individuals, teams and companies; he designs and delivers programs that are tailored to meet specific business needs.

Drawing on more than 20 years experience in the pharmaceutical industry, Guy is renowned for providing bespoke facilitation of leadership events, strategy teams and other business groups enabling them to become more effective. He has established a unique and highly successful coaching style which has helped senior executives improve the way they lead and drive their businesses forward.

Guy has extensive experience of applying improvement methodologies such as Lean Sigma in a manufacture and supply environment; gaining a reputation for delivering results with determination and enthusiasm.

He has held a number of senior operational management and leadership roles, operating across a wide range of geographic and cultural environments. His work has been proven to deliver significant change and improvement in global organizations.

JOHAN MOELICH

JOHAN MOELICH has a 30 year track record of delivering complex projects on schedule and on budget. His experience includes a wide range of projects from pharmaceutical and biotech manufacturing and R&D facilities to hospitals, clinics, mission critical installations and higher education facilities.

Johan was a founding partner and principal of Sims Moelich Associates, a firm focusing exclusively on project management. During Johan’s 24 years with the firm, SMA managed some of the most significant pharmaceutical facility projects in Canada, including GlaxoSmithKline’s corporate head office and manufacturing plant in Mississauga, Canada. Other pharmaceutical and biotech clients include Apotex, AstraZeneca, Cangene, CIBA, Connaught (now part of sanofi), NPS Pharmaceuticals and Hemosol.

Johan’s projects have ranged in size from a few hundred thousand dollars to $500 million.

PAUL COOK

PAUL COOK provides project management and technical expertise globally to the Pharmaceutical Industry.  Paul has delivered projects in Europe, Africa, South East Asia, North and South America.

With 22 years of experience gained in a wide variety of Pharmaceutical Industry roles, Paul is able to add value to all projects and related activities.  Beyond being a natural leader who can effectively manage project teams of all sizes and complexities; Paul has specific skills in pharmaceutical automation, process and equipment engineering, IT systems, qualification/validation (including GAMP), new product introduction, procurement, facility construction and commissioning.

D.BRUCE COHEN

D. BRUCE COHEN is a seasoned leader in the healthcare package engineering field with over 35 years of hands-on experience in diagnostic, consumer and Rx products, while working in R&D, manufacturing and above site corporate support groups.

Bruce is an innovative and energetic person with the ability to direct and prioritize multiple projects and collaborate with commercial, manufacturing, procurement and R&D cross-functional teams. He has extensive experience with FDA (cGMPs, bar codes, Serialization and anticounterfeiting), Consumer Product Safety Commission (CPSC) and industry groups (PhRMA, HDMA, NACDS, EFPIA, ASTM and GS 1). Packaging materials and processing experience includes blow molded and injection molded components, glass, metal, films, paperboard and corrugated.

Areas of prime interest to Bruce include innovation, anticounterfeiting, operational improvements, packaging technology, packaging transfers, primary and secondary packaging processes, labeling & graphic design processes, pack design, packaging start-ups and product/package/process trouble shooting.

SHAWN WHITFIELD

SHAWN WHITFIELD is a seasoned Life Sciences executive and proven leader of value-adding Process & Technology Development and Pharmaceutical Engineering functions. He provides clients with strategic technical and technology focused consulting, to realize significant Drug Development (R&D) and Manufacturing Operations benefits.

Shawn specializes in working with clients to identify and develop Drug Delivery and Manufacturing process and technology solutions.  Resulting investment strategies and roadmaps are integrated with the client’s business model, in order to maximize the benefits potential.

Shawn has over 26 years experience in Consumer Healthcare and Pharmaceutical R&D, Manufacturing Operations and Technical Services / Support organizations.  He possesses highly portable skills, experience and a versatile background.  Prior to leaving GlaxoSmithKline he led over a 12 year period multi-national, global teams, often as part of a wider matrix operation, in the areas of Product, Process and Technology Development.  As well as possessing a considerable understanding of manufacturing processes, across a wide range of pharmaceutical and consumer healthcare technologies, unit operations and dose forms, he is also recognized for having an invaluable combination of exceptional interpersonal skills, unquestionable technical knowledge and customer focused, business understanding.

MARK FUSE

MARK FUSE specializes in design, project engineering, integration, validation & compliance of pharmaceutical processes and systems. With experience in all pharmaceutical dosage forms in both sterile and non-sterile applications. Mark’s expertise encompasses  the specification of new equipment following detailed review of forecasts to ensure appropriate equipment sizing,   Equipment Tendering process, Design review  and Design Qualification (DQ),  Equipment Feasibility studies and Capacity Analysis,  Management of Equipment Installation, Commissioning and Site Acceptance Testing (SAT), and Process Improvement including change part management.

Mark provides Equipment compliance and  Validation support  including Installation Qualification (IQ), Operational Qualification(OQ),  Process Qualification (PQ),  cGMP Gap Analysis, plus help developing and writing Procedures and Policies.

AFSHIN HOSSEINY

AFSHIN HOSSEINY provides customer-focused quality assurance, regulatory compliance, and business improvement services globally to the pharmaceutical industry.

Afshin offers a comprehensive and professional Quality Assurance auditing service to identify areas for improvement and work with clients to generate realistic improvement plans. He is able to undertake pre-inspection audits and support site preparation for GMP and PAI inspections by MHRA and EC Inspectors and the US F&DA.

Afshin also provides a comprehensive range of GMP training courses in the UK and Europe.  These are designed to meet the needs of pharmaceutical, healthcare and biotechnology companies, plus the organizations that supply goods to, and distribute products for them.

Afshin speaks regularly at industry conferences and seminars in Europe and the USA.

JIM FALANGA

JIM FALANGA has provided business centric software product and application system solutions for over 35 years in a variety of disciplines and industries. For the last 10 years, Jim has specialized in providing management, planning, business process, software development life cycle, validation, application, infrastructure, third party product evaluation, 21 CFR Part 11 compliance, and testing consulting services to health and bio-pharmaceutical clients.

Jim’s expertise covers a wide range of domain and technologies. He has the ability to work  with non-technical and technical participants to resolve complex, cross functional issues quickly, decisively and effectively.

Jim has delivered results related to all aspects of software development life cycle and validation (compliance) process in a variety of projects including Laboratory Information Systems, Laboratory Information Management Systems, Clinical System Integration, Billing System Integration, Change Management Systems, Document Management Systems, and support systems.

PETER KLYM

PETER KLYM has managed operational teams and led international improvement programs in IT, QA and Supply Chain functions during a 27 year career split evenly between the automotive and pharmaceutical industries.

Peter provides Lean Supply Chain consultancy, training and operational support to companies in the pharmaceutical and healthcare sectors, working with manufacturers and their supply base to generate business benefits in terms of both service and cost.

Peter has most recently coordinated an international pharmaceutical supply chain rationalization program involving inter-site product transfers and a switch to low-cost sourcing, during which service levels were maintained and stocks and lead-times reduced by 30%. He has led numerous ERP and other system implementations in regulated environments, combining process optimization and technology to improve supply chain performance and product safety

BETH LINDSEY

BETH LINDSEY has led international teams responsible for sourcing products worth some $4bb in revenues from Pharma, OTC, and Biotech contract manufacturers across the globe. Her expertise includes strategic analysis and rationalization of large contract supply networks, strategic sourcing and contract negotiation. Her 25 years in the industry has resulted in a deep knowledge of the contract manufacturing offerings and contacts, resulting in her ability to pinpoint the right manufacturer for a client’s specific needs. She has extensive experience in supplier relationship management and creation of performance improvement plans to allow a CMO to respond rapidly to a client’s business requirements.

In addition, she has been integrally involved in both the acquisition and divestment of Pharma products from Phase II to products nearing the end of their life-cycle including authorized generics. She has led projects from initial due diligence to contract development and negotiation to final logistics and integration into the receiving company.

MURRAY ADAMS

MURRAY ADAMS specializes in Lean Six Sigma and Design for Six Sigma (DfSS) consulting organization supporting a wide variety of clients from various industries in the United States, Canada, Europe and Asia. With more than 20 years of experience in pharmaceutical development and production operations, Murray Adams specializes in supporting pharmaceutical QbD, PAT and process improvement initiatives using Six Sigma principles and tools.

Murray also provides Green Belt and Black Belt training in Lean, DoE, Six Sigma and DfSS tools and concepts. Post training support can be provided with coaching of trainees as they work through their process improvement projects. In addition he offers support through statistical experimental design and analysis of data related to product development, process troubleshooting and process optimization.

Murray Adams regularly presents at seminars and conferences. He has published articles on the application of Six Sigma and DfSS in a pharmaceutical environment and is a co-author of Lean Six Sigma: A Tools Guide which is used by government, industry and academia.

PHILIP KEICHER

PHILIP KEICHER is a registered pharmacist with over 25 years experience as a clinical supply professional. He provides strategy and direction to the planning and execution of clinical supplies in support of clinical trials globally.

Philip is a highly respected speaker and trainer, having organized and conducted seminars and workshops in clinical supply specialty areas including: Outsourcing and Working with Contractors; Blinding and Randomization; Stability Requirements for CTM; Global GMPs; Customer Service; Adaptive Clinical Trials.

His publications in professional journals, including Global GMPs for CTM; Process Mapping and Process Improvement; Pharmacy Services in The Surgical Suite.