large_Untitled-1.jpg

medium_Untitled-1.jpg

small_Untitled-1.jpg

thumbnail_Untitled-1.jpg

Untitled-1.jpg

team-2.jpg

Rajendra Nagori

A skilled researcher with an educational background in Pharmacy and worked in Pharmaceutical Formulation development field at various levels of management hierarchy.

More than 34 years of total experience in the field of Research and Development (R&D) for pharmaceutical products. He has an extensive experience in the development of formulations for Generic Pharmaceutical product development for US market, Generic Pharmaceutical Product development for Europe market, Formulation development of New Chemical Entities for various phases of clinical trials, Pharmaceutical Product development for Rest of the world market, pharmaceutical product development for Indian market, Injectable formulations for veterinary use

Rajendra has very good understanding in designing / setting up a state-of-art formulation development facility. His experience covers all stages of product life cycle. He has conducted due diligence for drug product manufacturing at third party manufacturing locations. Provides scientific justifications to address the queries raised by regulatory authorities during the review of dossiers.

He has been involved in the development of complex generics (LMWH, drug + device combination products). Attended and speaker in multiple training programs and conferences.

team-1.jpg

Dr. Vijay Tammara 

Vijay Tammara is Ph.D. in Pharmaceutics from the University of Louisiana, Monroe, LA. Prior to industrial positions, Dr Tammara held increasingly responsible positions in the Office of Clinical Pharmacology and Biopharmaceutics at US FDA and received several FDA awards including the CDER Outstanding Reviewer Award, FDA Outstanding Achievement Award, and Awards of Excellence.

Vijay is an AAPS member and received AAPS regulatory sciences achievement award in 2012. He served as editor for the journal, “clinical research and regulatory affairs” and continues to serve on the editorial board and is an adjunct faculty at University of Pacific, Stockton, University of Louisiana at Monroe, and SIUE, St. Louis. 

He is well experienced in providing strategic guidance for comprehensive drug development including New Chemical Entities (NCE), Generic, and Biosimilars.  In addition, he offers consulting and guidance for Product Registration, Health Agency Consulting and Liaison Services, filing and maintain regulatory submissions, and post approval life cycle management including 505(b) (2) strategy. His regulatory expertise spans both oral and injectable dosage forms of small molecules, peptides, proteins, monoclonal antibodies and vaccines. 

Dr. Vijay Tammara worked at Nuron Biotech Inc., Merck & Co. Inc., Wyeth Pharmaceuticals, and Sanofi-Aventis.

team-3.jpg

Manojkumar Agrawal

Manoj has more than 29 years of experience in various areas of pharmaceutical industry which includes Regulatory Affairs, QMS, Compliance, Vendor Audits, Manufacturing, Validations and Sterile API manufacturing. He has extensive experience / expertise in active pharmaceutical ingredients (API) and finished dosage form. His operational and analytical understanding are an additional benefit while designing a robust regulatory strategy for various complex projects. Well experienced in facing facility inspections conducted by regulatory authorities (US FDA, MHRA, EDQM and other Health Authorities). Manoj expertise includes submissions and approval of dossiers through various regulatory authorities including USA and EU. Attended multiple training programs and conferences.

WhatsApp Image.jpeg

Nayeem Syed 

Nayeem has more than 21 years of experience in various areas of pharmaceutical industry which includes Regulatory affairs, Quality, Regulatory Compliance and Formulation Development. He is well experienced in submissions and getting approval of dossiers through regulatory authorities including USA and EU. He has submitted multiple scientific advice/meeting packages to health authorities (USA and EU) for IND and generic products and participated into face-to-face meetings. He was responsible for designing regulatory strategies for oral solid (tablet, capsules), oral liquid, complex generics (LMWH, drug + device combination products, controlled release injectable). He has done regulatory due diligence / facility audits of both Indian and international companies (USA, UK, France, Canada, Belgium, China). Well experienced in facing facility inspections conducted by regulatory authorities (US FDA, MHRA, EDQM and other authorities). Has publication in national and international research journals. Attended (e.g. Culture of Quality) and was speaker in multiple training programs and conferences (e.g. GPhA USA).

team-4-removebg-preview.png

Dr.  Girish Jain 

Dr Girish Jain has an extensive experience of more than 33 years in Pharmaceutical Industry.  He is well experienced in Formulation & Development and regulatory submissions of various drug products.

Dr Girish Jain was the active team member in the development and scale up of Cipro OD, which was out licensed to Bayer (US).

Responsible for development, scale up and launch of Metoprolol XL tablets at Wockhardt. It was second generic approved against Toprol XL in 2010. Company has awarded Chairman’s Trophy to Dr Jain for approval and launch of the product.

Involved in filing and approval of multiple FTFs. 
Specialties: Formulation & Development of Solid Orals, Liquid Orals, Sterile dosage forms (Injectable and Ophthalmic), Topical and Transdermal Delivery system. 
Experience: 250 ANDAs and 505(b) (2) NDAs with US FDA, more than 50 generic products in Europe and more than 25 generic products in Australia (TGA).

Patents: Granted 28 patents in US and 150+ patents in Europe.

team-5.jpg

Dr Priyanka Mehta 

Dr Priyanka has 20+ years of experience and is consultant to generic pharmaceutical companies for handing their In-House IP issues and managing US Patent Litigations.

Professional experience in Patent Litigation, drafting Invalidation reports, non-infringement opinions, Freedom to operate opinions, patent drafting and prosecuting patent applications in several jurisdictions including India, US, CN, SG, NZ, EU, RU, KR, CA, AU, GB, Ukraine, EAPO.

Skilled in literature search and analysis using various databases including CAS, Delphion, IMS, Blast, PatentIn, Datamonitor, Newport, Lexis-Nexis, Courtlink, Totalpatent, Pacer, Orbit, Thompson Innovation, Generics Web.

No. of patent applications drafted and prosecuted till date: 400+ (including 56 PCT applications and 6 device patents; 86 US patent applications and 78 European patent applications). 
No. of patents granted: 270+ (including US, EP, RU, AU, SG, NZ) and No. of patent oppositions handled: 5 (Indian), 4(European).

No. of Commercial Contracts Agreements drafted and executed: 540+

Successfully managed US litigation of First to File and FON Products in 1/10thof the standard US Patent Litigation Cost (2017 Report of the Economic Survey AIPLA).

team6-removebg-preview.png

Ajay Kumar Srivastava

Ajay Kumar Srivastava has 38+ years of rich experience in Operations Management, quality assurance & regulatory compliances and API / Intermediate / Sterile / Oncology Plant design as per global regulatory requirements.
Good understanding of Regulatory framework with respect to manufacturing activities for both India and regulated markets overseas viz. USFDA / EDQM / UKMHRA / TGA / KFDA / PMDA / Italian drug agency / Greece Ministry of Health / MNC-CUSTOMERS (Pfizer / Sanofi / Sandoz / Ranbaxy / KRKA / Perrigo / Wockhardt / etc.).

team-8.jpg

Dr.  D G Kulkarni 

Dr D G Kulkarni has more than 35 years of experience in the domain of chemical research. 

Our Team