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First To File ( FTF) is the beginning of success.

FTF Pharma Ltd. Your partner of choice in identifying, analyzing, developing, scaling up, filing and commercializing your valuable products. First To File ( FTF) is the beginning of success. Vision :

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First To File ( FTF) is the beginning of success.

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  1. FTF Pharma Ltd.Your partner of choice in identifying, analyzing, developing, scaling up, filing and commercializing your valuable products. • First To File ( FTF) is the beginning of success.

  2. Vision : Our vision is to provide best and affordable solutions based on innovative thought process and their implementation. We aim to provide pharmaceutical solutions and services to the generic and branded pharmaceutical companies. • Mission : FTF Pharma Ltd aims to be one of the best pharmaceutical solution providers through consultation, innovation and development to meet the aspirations of its clients/partners .We plan to achieve the vision and mission through our experience and expertise in formulation development, patent understanding, pharmacokinetic expertise and innovative thinking .

  3. Services Offered • Identification of New Products. • Regulatory Strategy. • Non Infringing and IP strategy . • Business Development • Bioequivalence/ clinical trial strategy • Pharmaceutical Services • Investing opportunity • We infuse confidence in implementation of our solutions to our partners

  4. Identification of new products The first and most critical step of a business process is to select the best and most profitable product. Based on the huge data base and experience in generic industry, FTF Pharma offers its expertise in selecting the best product which is best fit to the clients’ portfolio and need. • Scientific, legal and commercial analysis of a products. • Technological feasibility, competition analysis, cost of development and Return on Investment projections. • Incremental innovations to work around maze of patents and make the product niche . • New Dosage Form, New Combination and New Drug . • Product differentiation and life cycle management of high value products.

  5. Strategic Regulatory Services • Regulatory Strategy is the key to optimizing the development resources for global development of API and finished products. • Assess the global regulatory landscape based on each local regulatory and market needs ( ANDA,ANDS,MA’s though DCP or CP or MRP etc). • 505(b)2 and Pre NDA preparations. • Collaboration between API and Drug Product companies for mutual benefit. • DMF/COS evaluation to limit the resources of its clients to bare minimum. • Mock up audits for its clients for their API/FP and BE/CT sites to preempt issues well in advance . • Formulate CMC and BE/CT related queries effectively on time.

  6. Patent Strategy • Evaluation and Recommendations of API and Drug product for IP landscape across the globe. • Product, process, method of use patent for US,Canada,EU and ANZ markets. • Formulation patents. • Polymorph selection. • Patent opinion. • Patent notifications and Responses. • Litigation advise and identifying right legal attorney for different markets . • Settlement/ litigation strategy.

  7. Business Development • CRAMS model • Out licensing deals with supply • In licensing and due diligence • Extending products to new markets • Strategic Collaboration/ tie ups • Contract Manufacturing tie ups

  8. Bioequivalence & Clinical Trials • Right Designing of protocol. • Organizing CRO • IVIVC and IVIVR studies • BE/CT failure investigation and reformulation strategy. • BCS waiver • Impurity qualification • Genotoxicity evaluation.

  9. Pharmaceutical Services • Forward integration of API companies. • Backward Integration of Finished Dosage Forms (FP) companies. • Infrastructure Development ( Man, Machine ). • QbD Implementation . • Galenical/Lab scale Oral, Topical and Injectable Formulation Development. • Formulation Development of NCE • Bioavailabiltiy Enhancement of API through Formulation. • Formulation upgradation • Technology Transfer. • New Dosage Form • New Combinations. • s-New Drug Applications.

  10. Investing Opportunities • Project Based Funding. • Better EBIDTA. • HNI/Angel Investor Funding. • ROI Analysis • Due Diligence of projects, ANDA’s, IP’s.

  11. Expertise of Lead Consultant • Jayanta Kr Mandal, M.Pharm has 20 years experience in Pharma R&D, IPR & business development. Worked in top 10 companies in India. • Lastly headed R&D, Patent cell and Pharmcokinetic cells and managing product selection ,all BE and CT studies for the company for all regulated and semi regulated markets. Also actively involved in business development for dossier and toll manufacturing businesses. • Mr. Mandal has wide range of experience in developing Immediate Release,Sustained Release, MUPS Oral formulations , Liquid and Lyophilised oncology and general Injectableproducts,Topical Dosage forms, Ophthalmic Dosage forms and Liquid Oral Products through s NDA ,ANDA,DCP,CP,MRP and national procedures. • Mr. Mandal has experience in dealing with US and EU patent attorneys and counsels for patent opinion, document discovery, deposition etc leading to settlement or legal outcome.

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