WORK and STRATEGIZE with our Proven Professionals

The difference we bring to the projects is that our team provides hands-on expertise which ensures high level of support for your ongoing activities . Our team members also have cross-functional experience in the other disciplines

Dr. Ravi Malhotra, Ph.D.

Founder and Managing Partner

Dr. Ravi has had over 30 years experience experience in drug development and pharmaceutical production. His scientific and technical skills are impressively supplemented by an ability to effectively manage the FDA filings and approval process. He was directly responsible for development, submissions and FDA approval of over 100 products at American Pharmaceutical Partners (APP)and Sagent Pharmaceuticals. This brought both companies to the forefront of the specialty generic parenteral companies and were sold or turned around for billions of dollars.

In the area of GMP compliance, Dr Ravi steered Fujisawa through a thorny Application Integrity Policy Process before the FDA. He coordinated and brought 150 products and 300 analytical methods into GLP and GMP compliance in a period of nine months.

In the corporate development, his extensive experience in evaluating and utilizing the Indian Pharmaceutical landscape for highly skilled and cost-effective resources to bring Sagent Pharmaceuticals to the forefront of the American industry.

Dr Ravi has several years of teaching and fundamental research experience in the Universities of Missouri, Kansas and Ohio.

Sandeep Dayal and Group

Marketing Research and Market Penetration Partners

MBA from the Yale School of Management. Twenty years of experience in consumer facing industries and consulting. Worked in marketing and operations with Unilever and as an Associate Partner in McKinsey’s marketing and sales practice. Served over 30 clients around the world. He works as a counselor to C-suite executives and board members at Fortune 500 companies. He is regarded as one of the leading minds in Marketing Strategy and has co-authored articles in Marketing Management, McKinsey Quarterly and Strategy & Business. Sandeep has supported leading pharma companies including AbbVie, Pfizer, Baxter, Thermo Fisher, Sagent, Horizon and Abbott.

In addition, our group has over 20 years of experience and a deep knowledge of generic pharmaceuticals and medical devices. We can provide market intelligence and market access strategies to help navigate your product(s) through the healthcare of trade ( Acute and Non Acute ) through our relationships and knowledge of supply chain segments including but not limited to, Group Purchasing Organization’s (GPOs), Hospital Systems, Integrated Health Networks, Integrated Delivery Network and Primary and secondary wholesalers for distribution needs.

Jonathan Booth, MBA, MSRC, MSME

Specialty Network Development , Partner

Jonathan has over 25 years of experience in the biotech, pharmaceutical, and medical device industries. Most notably, Jonathan has served as the Senior Vice President of Program Management and Strategic Initiatives for NantPharma, LLC, a biopharmaceutical subsidiary of Nant Holdings, where he was responsible for product portfolio development and commercialization. He has held senior positions at Liminal Biosciences Inc., Celgene Corp, Fresenius Kabi AG, Baxter Healthcare Corporation, and Pfizer Corporation where his experiences included commercial operations, program management, business development, operations management, operations excellence, and finance.

As Vice President of Commercial Operations for Liminal Biosciences Inc., Jonathan was responsible for all aspects of commercial operations, which included establishing a specialty network system for an ultra-orphan drug. In preparing for the launch of the ultra-orphan drug, he gained a deep understanding of the operations and integration of specialty networks comprised of specialty pharmacies, specialty distributors, hub service providers and third-party logistic providers. Specifically, Jonathan was very successful in securing favorable terms with his specialty network partners.

Jonathan holds an MBA from the Kellogg School of Management, Northwestern University. Additionally, he holds a M.S. in Regulatory Compliance from Northwestern University, and a M.S. in Mechanical Engineering from the University of Michigan.

Madan Chilakuri, M.S., R.Ph.

Regulatory Partner

Madan Chilakuri is a regulatory affairs professional with background in NDA 505(b)(2) and ANDA submissions. He has experience in many business functions including regulatory affairs, quality, good manufacturing practices (cGMP), Drug/Devices, Establishment Registrations and eCTD compilation/publishing and submissions to FDA.

During his career Madan facilitated successful submission of ANDAs, including priority review ANDA approved in less than 4 months. He also participated in multiple Pre-IND meetings of 505(b)(2) NDAs (Injectable and liquid oral dosage forms) and obtained waiver of clinical studies requirement for the NDAs. Madan has clear understanding of regulatory requirements of NDAs and ANDAs and has worked with product development teams to prepared documents to support US FDA Filings.

Madan has been acting as US Agent for multiple organizations facilitating FDA communications and Drug/Device/Establishment registrations. He has extensive experience in regulatory strategy and preparing responses to FDA deficiencies. He has expertise in eCTD compilation and submission of the ANDA, NDA and DMF filings to FDA as well as lifecycle management of approved products. Madan is a board certified pharmacist in the state of Wisconsin and has a M.S. degree in Chemistry and B.S. in Pharmacy.

Dr William Zhao, Ph.D.

Preclinical and Clinical studies Planning Partner

Dr. William Zhao has over 30 years of experience in drug development area. He has held several scientific and managerial positions and responsibilities with major Pharmaceutical companies in the US and China. He has vast expertise and experience of strategic planning and implementation of preclinical and clinical development along with regulatory submissions at various stages of development. He has successfully led small to large size pharma products from early development to completing study design and completion of the studies leading to NDA approvals. He has also been successful at fund raising and closing several licensing deals.

Dr. Siddharth Malhotra, MD

Dr. Sid is a surgeon for over 15 years having done his training with UC San Diego and affiliates. He works in close association with physicians at Levine Cancer Center in the fight against cancer using cutting edge technologies in Biologics, Gene Therapy and Stem Cell Therapy. He is also well-versed in medical devices and surgical technologies. He is a great resource with insight in frontline usage and efficacy