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 Technical 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 Technical 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

Vice President, Head of CMC Development and Project Management

Ray received his Ph.D. in Organic Chemistry from the University of Illinois at Chicago and completed his MBA from Babson College. Ray has over 13 years of experience in the Pharmaceutical industry working for both pharmaceutical and CRO/CMO companies. At Syner-G, Ray is a member of the Senior Leadership team having responsibility for leading the CMC and Project Management business units. His team is responsible for providing scientific solutions for drug development programs including identifying and managing CRO/CMO/CDMOs for Syner-G’s clients to support drug substance, drug product and analytical development activities. Ray’s scientific team is also tasked with providing strategic and Program Management oversite of development and clinical stage programs. 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.

Rob Fraser, M.Sc.

Senior Director, Head of Quality and Compliance

Rob has a Master’s degree in Synthetic Organic Chemistry from the University of New Brunswick where he also completed his undergraduate studies. Rob has over 25 years’ experience in the pharmaceutical industry at a variety of companies. Rob was previously employed at Sunovion Pharmaceuticals (formerly Sepracor) as an Executive Director of Quality Operations. At Syner-G, Rob is responsible for heading up the Quality and Compliance team. His team will offer services supporting Quality Systems, Quality Operations, Quality Assurance, Quality Control as well as Quality Engineering and Product Complaint functions. Rob’s team comes with a track record of achievement in both R&D and commercial products.

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.

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.

Anuj Kumar, Ph.D.

Associate Director, Pharmaceutical Development/CMC Project Management

Anuj has a Ph.D. in Pharmaceutical Sciences from the University of Wisconsin, Madison and over 11 years of industry experience in pharmaceutical development at Vertex Pharmaceuticals. His areas of expertise include enabling formulation technologies such as amorphous spray dried dispersions (SDD), solid nanocrystalline dispersions (SNCD), lipid based formulations and nanosuspensions for the development of BCS class II compounds. Anuj has a strong background in materials science and a deep understanding of the interplay between functionality and bioperformance of a dosage form. He has authored relevant CMC sections for IND/CTA filings and is well versed with the change control system in a regulated environment. At Syner-G, Anuj is responsible for providing technical solutions to support/troubleshoot the development of client’s compounds.

Melody Mak-Jurkauskas, Ph.D.

Senior Manager, Regulatory Affairs

Melody received her Ph.D. in Biophysical Chemistry from Brandeis University and then went on to a complete a Postdoctoral year at MIT. She earned her undergraduate degree at the University of Toronto. Most recently she worked for Xtuit, BIND, Amgen and Alkermes. At Syner-G, Melody will work with the Regulatory Affairs team to offer CMC analytical support to clients. She has various experience operating as an analytical technical lead in drug development activities. Melody will also be working other members of the regulatory team to support numerous pre and post approval submissions to US FDA and other global health authorities.

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.

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.

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.

Avani Shah, M.S.

Jr. Consultant, Regulatory Affairs

Avani has a Master’s degree in Pharmaceutical Sciences from India and a second Masters in Regulatory Affairs from Massachusetts College of Pharmacy. Avani has worked as a Regulatory Associate at Zimmer Biomet where she was involved in authoring Summary Technical Documents for Legacy Products. At Syner-G, Avani is responsible for authoring post approval submissions and IND Amendments for numerous clients. She also manages electronic document management systems for archival and life cycle management of regulatory submissions. Avani also has experience providing regulatory support and authoring for IND/NDA annual reports for various clients.

Matt Pereira, B.S.

Office Manager

Matt holds a B.S. in biology from Boston University and five years of experience in the pharmaceutical industry. Prior to joining Syner-G, Matt worked for four years as office manager for a Massachusetts-based CRO where he was responsible for various operational tasks including invoicing, generation of proposals and overall handling of client relationships. At Syner-G, Matt is responsible for developing and executing client proposals and contracts, placement of off-site consultants and marketing initiatives as well as management of the Boston office. Matt also heads up other operational activities such as accounts receivable and human resources for Syner-G.

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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