Syner-G Pharma CMC Consulting | Our Team
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Our Team

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


At Syner-G, Binesh leads business strategy and operations. He has more than twelve years of experience in Life Sciences, mainly supporting IT functions including Compliance, Auditing, and Validation. In addition to Syner-G, Binesh is a Partner at Cambridge IT Compliance, an IT organization supporting Life Sciences.

Binesh received his Bachelor of Science in Engineering from St. Joseph’s College of Engineering (affiliated to the University of Madras, India); his Masters of Science in Environmental Science from Texas A&M University-Corpus Christi, Texas, and his Masters of Business Administration from Babson College, Massachusetts. Outside of work, Binesh plays cricket for United Athletic Association Cricket Club, affiliated to Massachusetts State Cricket League.

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.

Marsha Marande, Ph.D.

Vice President, Regulatory Affairs

Marsha received her Ph.D. in inorganic chemistry from the University of New York at Binghamton and her BA in Chemistry from Hamilton College. She is an experienced pharmaceutical professional with extensive experience in global CMC regulatory affairs (26 years) for both biotechnology and small molecule products in all phases of clinical development and post-approval. She has extensive experience in process validation, QbD, comparability assessments and protocols, authoring global submissions and responses to Agency queries. She is experienced in defining CMC strategy for early development and late-stage/commercial development of both for biologics and small molecules. She is an accomplished regulatory leader/manager in both early development projects (resulting in successful CTA and IND submissions) and full development programs overseeing the preparation of and successful submission of marketing applications (4 NDAs, 5 MAAs, 3 BLAs). Demonstrated leadership in leading and managing Teams (comprised of internal members as well as partners and vendors) through complex global submissions, difficult supply issues, formal meetings and interactions with numerous global health authorities (including FDA, EMA, Health Canada & several regional health authorities).

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.

William O’Brien, Esq

General Counsel and Vice President, Operations

Senior business and legal advisor and executive with extensive corporate and technology intellectual property and transactional experience. Extensive experience in establishing, counseling and representing US and international companies and individuals. Strong commercial focus and solution orientation, from negotiations through execution and operational phases. Extensive law firm, in-house and government experience with intellectual property and commercial issues. Corporate development expertise focusing on the critical transition period from entrepreneurial start-up/early stage companies to professionally managed organizations with the operational and compliance processes necessary to nurture and grow businesses. Industry experience primarily in the fields of pharmaceutical and medical devices, software, hardware, fashion and consumer products. Operational roles in coordinating strategic relationships with investors, suppliers and customers, as well as international expansion. Specialties: Trademark and copyright prosecution and enforcement, contracts, licensing, corporate governance and other commercial and operational matters.

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.

Velvizhi Heine, Ph.D., RAC

Director, Regulatory Affairs

Velvizhi earned her Ph.D. in Biochemistry from the Cancer Institute in Chennai, India and her BS/MS from the University of Madras in India. She is a pharmaceutical professional with strong background and experience in CMC Regulatory/Quality and Analytical Sciences for biologics, medical device and IVD industries. She has strong experience in method development and validation of analytical assays including bioassays and process impurity assays for a wide range of biopharmaceutical products including monoclonal antibodies, recombinant proteins, biosimilar, blood coagulation factors, enzymes and cell derived vaccine. Track record experience in QC, Analytical development, CMC and CRO management. Authored sections for BLA, 510K and PMA submissions; hold US Regulatory Affairs Certification (US RAC). Experience in drug product release sample testing, support for internal and external lab audits; proven record of scientific presentations at several national and international conferences. Strong organizational and communication skills with the ability to manage multiple projects simultaneously.

Anuj Kumar, Ph.D.

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.

Milind Dixit, Ph.D.

Director, CMC Formulation Development and Operation

Milind is a Pharmaceutical technologist with Ph.D degree in Pharmaceutical Technology from University of Bombay (now ICT), India. He has over three decades of global pharma industry experience, most of which is from working with the US Pharma & biopharma companies. He also has extensive working experience with CMOs and CDMOs in Canada and the U.S.

Milind’s area of expertise include CMC/product & process development (QbD approach), process validation, manufacturing as well as Tech Ops support, troubleshooting, technology and site transfers, authoring and reviewing documents such as BMRs, protocols and reports in support of above activities, Module 2 and 3 for ANDA filing and IND updates. For last 5 years he has been working as a consultant for the various US based pharma companies.

Lyndon Marble, Ph.D.

Associate Director, CMC Development and Project Management

Lyndon has a Ph. D. in Organic Chemistry from the University of Illinois at Urbana-Champaign and over 16 years experience in the pharmaceutical industry. For five years he was a team leader in the Medicinal Chemistry division at Johnson Matthey Pharma Services. The remaining time he has been in process chemistry research and development at both small biotech and CRO/CMO companies. His area of expertise is successful drug substance development, including route screening, route selection, and analytical method development, through to GMP Phase II kilo lab campaigns. He has participated in successful tech transfers to internal and external partners and has contributed to several CMC sections. Previously, Lyndon was a Senior Research Scientist at Laurus Synthesis, Inc., in Woburn, leading teams in process chemistry R&D for internal and external clients. His responsibilities at Syner-G are chemistry and project management support for clients’ drug substance development efforts.

Venkata Ratnala, Ph.D.

Senior Manager, Regulatory Affairs

Venkata received his Ph.D. in Biochemistry and Biophysics from Leiden University, The Netherlands and then went on to a complete his Postdoctoral Fellowship at Stanford University, USA. At Syner-G, Venkata is a member of the Regulatory team, he authors various regulatory documents including CMC documents, provides pre-and post-approval submissions, and offers CMC analytical support for clients. In his ten years in the industry, he has advanced various biologics, peptides and small molecules candidates under development to commercial by performing process development, analytical methods, formulation development and stability. Prior to Syner-G, he worked for CuriRx, UCB Pharma and Vertex Pharmaceuticals.

Amy Clark-Stasiw

Manager, Regulatory Submissions and Documentation

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.

Wayne Schairer, M.S.

MS – Manager, CMC Development and Project Management

Wayne earned his MS(Organic Chemistry) and BS(Chemistry) from Bucknell University. Wayne has over 25 years experience in the pharmaceutical industry. He has worked for over 15 years in the medicinal and process chemistry groups at Ironwood as well as 9 years in the medicinal chemistry group at Vertex before joining us at Syner-G. Wayne has an outstanding track record in the pharmaceutical industry delivering clinical candidates, API, and technology innovations to the company’s pipeline. Team-oriented and cooperative leader with extensive analytical, problem-solving and communication skills.

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.

Consultant II, 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.

Gajaan Sittambalam, B.S.

Consultant I, Regulatory Affairs

Gajaan has a Bachelor’s degree in Biology from the University of Pennsylvania. At Syner-G, Gajaan is responsible for authoring post approval submissions in a timely and organized manner. Gajaan has also attended and organized gene therapy and biologics training sessions among the Syner-G team.

Sree Hemanth Tummala, M.S.

Consultant I, Regulatory Affairs

Sree has a Master’s degree in Regulatory Affairs for drugs, biologics and medical devices from Northeastern University. Sree also has a Doctor of Pharmacy from India. At Syner-G, Sree is responsible for authoring post approval submissions and other regulatory amendments for numerous clients.

Geetha Tula, M.S.

Consultant I, Regulatory Affairs

Geetha has a Master’s degree in Chemistry-Molecular Biochemistry from Sacred Heart University and a Bachelor’s degree from India in Pharmacy. Geetha has worked as a CMC Regulatory Specialist at Merck where she was involved in Executing regulatory Post-Approval filing strategies and variations for global products while ensuring that all regulatory documents are prepared accurately, completely and on-time. At Syner-G, Geetha is responsible for authoring post approval submissions and providing CMC regulatory support for Syner-G clients for investigational and marketed products.

Anu Peter, M.S.

Consultant I, Regulatory Affairs

Anu has a Master’s degree in Drug Regulatory Affairs from Long Island University and a Bachelor’s degree in Chemistry from Pace University. Anu has worked as a Quality Assurance Associate at Sigmapharm Laboratories where she was involved with review, and approval of batch records of pilot submission, ANDA submission, scale-up and commercial batch records. At Syner-G, Anu is responsible for authoring post approval submissions and providing CMC regulatory support for Syner-G clients for investigational and marketed products.

Sanjana Reddy, M.S.

Consultant I, Regulatory Affairs

Sanjana has a Master’s degree in Regulatory Affairs and Quality Assurance from Temple University and a Bachelor’s degree in Cell and Molecular Biology from the State University of New York at New Paltzs. Sanjana has worked as a Clinical Research Coordinator at the University of Pennsylvania Surgery department where she was involved with preparation all regulatory documentation in Phase II/III clinical trials for investigational drug and device products. sAt Syner-G, Sanjana is responsible for authoring post approval submissions and providing CMC regulatory support for Syner-G clients for investigational and marketed products.

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.


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

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

Dr. Gary Maier
MaierMetrics Consulting


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