Syner-G Pharma CMC Consulting | Our Team
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Our Team

Prabu

Prabu Nambiar, Ph.D. MBA, RAC

Principal and Founder

Prabu acquired his Ph.D. in Organic Chemistry from Oregon State, completed his post-doctoral training at Brown University and got his Executive MBA from Boston University.  He has over 25 years of industry experience including last 20 years in CMC Regulatory Sciences.  His extensive CMC experience includes resolution of complex CMC/Quality and Compliance issues (regulatory starting materials, Genotox impurities, specifications, QbD implementation, PAI responses) using science and risk-based approaches and leading NDA/Regulatory Teams.  He has worked in various therapeutic areas and on a broad range of dosage forms including immediate and modified release oral products, inhalation products, sterile injectables and drug-device combination products.  He has led the filing and approval of 11 NDAs, numerous sNDAs, INDs and international filings.  He is a member of RAPS, ACS and AAPS and was the chair of Regulatory Science section at AAPS.

Binesh Prabhakar, MBA

Partner

Drew Barlow, M.P.H.

Vice President, Head of Regulatory Affairs

Drew holds a BS Degree in Biology from Mount St. Mary’s College and a Master’s in Public Health from University of North Carolina at Greensboro.  Drew has over 14 years of regulatory experience, including 4 years with the US FDA as a GMP investigator. He maintains extensive knowledge of global pharmaceutical CMC regulations and guidance documents pertaining to products in clinical development through post-marketing applications commercialization with emphasis in the EU, USA, Canada, Japan, China and Australia.  His areas of expertise include: devising and implementing CMC strategies, IND/IMPD/NDA/MAA preparation, post-approval compliance and regulatory reporting, GMP inspection readiness, and Quality by Design implementation.

Edward Ciolkowski, Ph.D.

Vice President, Head of CMC Development and Outsourcing Management

Ed received his Ph.D. in Analytical Chemistry from University of North Carolina, Chapel Hill and has over 20 years of industry experience in pharmaceutical development and management at Pharmacia-Upjohn, Pfizer and Bausch and Lomb.  At Syner-G, Ed heads up the CMC Development and Outsourcing function and his team is responsible for providing both strategic stewardship and tactical solutions for the scientific and technical aspects of drug development programs, including biopharmaceutical components such a dissolution and bioequivalence.  His team is also responsible for identifying and managing CRO/CMO/CDMOs for Syner-G’s clients to support drug substance, drug product and analytical development activities.

Ray Forslund, Ph.D. MBA

Senior Director, CMC Business Development & Project Management

Ray received his Ph.D. in Organic Chemistry from the University of Illinois and completed his MBA from Babson College.  Ray has over 11 years of experience in the Pharmaceutical industry working for both pharmaceutical and CRO/CMO companies.  At Syner-G, Ray leads the business development and project management efforts along with providing CMC technical consultations. Previously, Ray was part of the Senior Leadership team at Laurus Synthesis Inc. (LSI), a Boston based CRO/CMO where he led the Project Management group. He began his pharmaceutical career as a process chemist at Vertex Pharmaceuticals then moved on to Ironwood Pharmaceuticals holding several scientific positions of increasing responsibility leaving as a Senior Manager of Operations.

Sarah Hlavachek, B.S.

Director, Regulatory Affairs

Sarah holds a BS in Chemistry from University of Wisconsin, Madison. She began her career in pharmaceutical development as an analytical chemist at PPD Development and Sepracor and then moved to CMC regulatory affairs.  Sarah has over 16 years of experience in CMC regulatory affairs for small molecules, biotechnology products and drug device combination products. She has managed several regulatory submissions at various companies across all stages of development, from pre-submission consultation meetings (pre-IND), Phase 1 through 3 clinical trial applications, to marketing applications and post-approval supplements.  Her global CMC experience includes submissions in the US, Europe, Japan and Canada for investigational and marketed products.

James Bush, B.S., MBA

Associate Director, Regulatory Affairs

James holds a B.S. in Biochemistry from Union College and recently completed his M.B.A. from Babson College with a focus in Business Analytics. He has over 10 years of pharma industry experience with a successful track record as an Analytical Chemist and as a CMC Regulatory Affairs professional.  He takes a strategic approach to decision making with an emphasis on sound scientific principles.  James played an integral part in the successful commercialization of three drugs and the effective introduction and management of multiple compounds in various phases of global development.   James began his pharmaceutical career Pharmaceuticals as an Analytical Chemist and subsequently transitioned in to a CMC Regulatory Affairs professional.

Jay Samudralwar, Ph.D.

Director, Regulatory Affairs

Jay received his Ph.D. in Analytical Chemistry from India and completed his post-doctoral training at University of Kentucky, Lexington.  Jay has over 17 years’ experience in Global Regulatory CMC & Conformance, Quality Operations and Quality Control in Pharmaceutical & Biotechnology Industry. He started is pharmaceutical career at Merck and subsequently worked at Wyeth/Pfizer.  Jay has a proven track record of developing global regulatory strategies, execution, eCTD submissions and direct interactions with the Boards of Health for developmental / established products (Branded & Generics).  He has led technology & site transfer projects for APIs, sterile, non-sterile, biotechnology products and supported PAI/cGMP inspections with successful outcomes.

Bharathi Mamidipudi, M.S.

Consultant II, Regulatory Affairs

Bharathi has a Bachelor’s degree in Pharmacy from India and Master’s degree in Regulatory Affairs of Drugs, Biologics and Medical Devices from Northeastern University, MA.  Bharathi has comprehensive knowledge of CMC regulatory requirements for investigational and marketed products. Bharathi has 4 years of CMC Quality and Regulatory experience, including 3 years of CMC regulatory affairs in developmental and post marketing activities. Her experience includes authoring and reviewing Module 3 and Module 2.3 (CMC) sections of CTD submissions in both small and large pharma settings.  She has supported numerous of pre and post approval submissions to US FDA and other global health authorities for various clients.

Amy Clark-Stasiw

CMC Technical Writer, Regulatory Affairs

Amy has over 20 years of experience in the pharmaceutical industry. She started out as a microbiologist/bench chemist and worked her way through the different facets of the business including quality, analytical, stability and lastly regulatory. Ms. Clark-Stasiw has authored IND, IMPD, NDA, ANDA, CBE and PAS submissions, as well as, Annual Reports for regulatory agencies in the US, Canada and Europe. Ms. Clark-Stasiw is also very experienced in preparing submissions for electronic publication (gateway ready documents) and understands the publishing needs of regulatory operations teams.

Rajan Thumar, M.S.

Jr. Consultant, Regulatory Affairs

Rajan has a Bachelor’s degree in Pharmacy from India and Master’s degree in Regulatory Affairs from Massachusetts College of Pharmacy.  Prior to Syner-G, Rajan worked as regulatory team member at RiconPharma LLC, NJ where he was involved with entire product life-cycle pertaining to regulatory affairs, quality assurance and compliance.  Rajan has thorough understanding in pharmaceutical manufacturing, quality control as well as the CMC regulatory requirements for investigational medicinal products and post-approval marketed products.  He has provided CMC authoring and regulatory support for INDs, sNDAs and IND/NDA Annual Reports for various clients.

Advisors

Dr. Patrick DeLuca
Professor Emeritus, Pharm. Sciences
University of Kentucky

Dr. Neal Anderson 
President, Anderson’s Process Solutions
Ex-BMS
API Process and Manufacturing

Dr. Steven Koepke
SRK Consulting, LLC
Ex-FDA Deputy Director

Dr. Gary Maier
MaierMetrics Consulting
Ex-Sanofi/Sepracor/Sunovion
Biopharmaceutics

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