Nitin Saigal, Phd Email & Phone Number

Haridwar, Uk, In

Haridwar, Uttarakhand, India

Haridwar, Uttarakhand, India

Leading 70+ in two Synokem R&D units for development of OSD, Liquids, Semi solids & multiparticulates, while reporting to Managing Director.Leading F&D, ADL, RQA, documentation & Project management verticalsManaging projects related to DCGI, P2P, Exports, Institutional supplies, Ethical marketing & AVD work streams.Managing 80+ pipeline projects at different stages of development for domestic & export market, from inception, development, technology transfer… Show more Leading 70+ in two Synokem R&D units for development of OSD, Liquids, Semi solids & multiparticulates, while reporting to Managing Director.Leading F&D, ADL, RQA, documentation & Project management verticalsManaging projects related to DCGI, P2P, Exports, Institutional supplies, Ethical marketing & AVD work streams.Managing 80+ pipeline projects at different stages of development for domestic & export market, from inception, development, technology transfer, commercialization & troubleshooting.Driving technologies & projects selection for current & future pipeline from medical, technological & pharmaceutical perspective.Executing the approval process with hiring, reporting, dashboarding & framework development for holistic view of R&D.Accessing potential risks & deriving mitigation plans while guiding regulatory dossier preparation and addressing regulatory queries.Preparing systems & products for DCGI approval while leading cross functional matrix teams for product development, commitment & delivery of new products.Enabling launch readiness for products by executing local BE and clinical studies while encouraging multi-channel engagement.Worked with user groups across BUs (3 Manufacturing locations), BD, Market Research, Clinical Research, CQA, Regulatory, pharmacovigilance, Finance, Compliance & Information Solutions at affiliate & regional levels to orient business processes towards objectives.Delivering scientific & evidence backed leadership to brand/product life cycle, cost-effective deliverables, financial plan development, & following the budgeted expenses to minimize variation between budgeted & actual expenditure.Paving the way for high performing teams by nurturing talent, providing resources, creating learning opportunities.Delivered pre-& post-commercialization client support. Reducing cost of products as a part of lifecycle management, competition improvement programs for next generation products. Show less

New Delhi Area, India

Spearheaded New Technology, Formulation and Product Development as the lead involving exploratory science initiatives,brainstorming, identification and implementation of innovative, impactful and formulation platform technologies / delivery systems.Increased performance and patient compliance that minimizing existing barriers to vaccination.Led low-cost novel intradermal vaccine delivery technology (Microneedles- Microarray Patch) with different antigens to address the needs… Show more Spearheaded New Technology, Formulation and Product Development as the lead involving exploratory science initiatives,brainstorming, identification and implementation of innovative, impactful and formulation platform technologies / delivery systems.Increased performance and patient compliance that minimizing existing barriers to vaccination.Led low-cost novel intradermal vaccine delivery technology (Microneedles- Microarray Patch) with different antigens to address the needs of the developing world. In addition, leading formulation development of all vaccines in HL pipeline.As Partner Identification and collaborator lead, negotiated and facilitated collaborations and idea extension to a level of maturity within-house optimizations and external partnerships.Owned Product development strategy, budget preparation and forecasting, competitive landscaping, fund raising support (submissionof RFPs) and regulatory meetings.International project coordinator and lead for Hilleman Laboratories in national and international forums, WHO and PATHcorrespondences, PDVAC and participations.Managed IP portfolio involving value addition to proprietary/existing technology platforms, Expanding IP portfolio with novel technology platforms and products, coordination with IP agents, budgeting, response submission.Took ownership for Scientific writings involving Research manuscripts, RFPs and Grant proposals.Handled technical and alliance management for formulation with analytical activities while leading formulation associate scientists.Managed product optimization and development for preclinical and clinical trials, manufacturing support. Show less

Maharashtra

Led 10 scientists for formulation, technology transfer, scale up and launch of solid orals & DPIs for domestic, emerging & EU markets.Developed products right from project initiation, formulation development, stability evaluation, pack identification, technology transfer,plant scale up, launch activities, cost improvement, quality improvement, product site transfer and alternate vendor development. Developed products for emerging markets with leverage from domestic… Show more Led 10 scientists for formulation, technology transfer, scale up and launch of solid orals & DPIs for domestic, emerging & EU markets.Developed products right from project initiation, formulation development, stability evaluation, pack identification, technology transfer,plant scale up, launch activities, cost improvement, quality improvement, product site transfer and alternate vendor development. Developed products for emerging markets with leverage from domestic development, extension of US/EU developed products andcommercial documentation support to plant.Prepared documents and reports as per GMP requirements and for regulatory submissions. Collaborated with cross functional teams and stakeholders and strategy, project management, supply chain, marketing, business,Intellectual Property, Regulatory, SAP, Analytical, Packaging, Medical, CMS, Plant) from project initiation to commercialization stage. Show less

New Delhi Area, India

Particle engineering and formulation development of affordable and thermostable oral vaccines for developing world use.Formulation development, stability evaluation, scale up of heat stable vaccines and proteins in solid dosage forms. Particle engineering and thermostabilization by Spray Drying including scale up.Granulation/tableting, encapsulation, Fluid bed processing, MUPS, DR enteric coatingsPack identification and development activitiesTechnical… Show more Particle engineering and formulation development of affordable and thermostable oral vaccines for developing world use.Formulation development, stability evaluation, scale up of heat stable vaccines and proteins in solid dosage forms. Particle engineering and thermostabilization by Spray Drying including scale up.Granulation/tableting, encapsulation, Fluid bed processing, MUPS, DR enteric coatingsPack identification and development activitiesTechnical discussions with collaborators and management Show less

Hyderabad

Led formulation development, stability analysis and launch for 8 unit dose Dry Powder Inhaler formulations with formoterol,budesonide, fluticasone & Tiotropium for domestic & emerging markets.Managed Spray drying &b particle engineering of powders for inhalation and Device Engineering for DPIs & new device development.Led dry/wet radiolabeling of above drugs with Tc-99m and radioactive imaging by Gamma Scintigraphy to capture lung depositionpatterns and PK evaluation in… Show more Led formulation development, stability analysis and launch for 8 unit dose Dry Powder Inhaler formulations with formoterol,budesonide, fluticasone & Tiotropium for domestic & emerging markets.Managed Spray drying &b particle engineering of powders for inhalation and Device Engineering for DPIs & new device development.Led dry/wet radiolabeling of above drugs with Tc-99m and radioactive imaging by Gamma Scintigraphy to capture lung depositionpatterns and PK evaluation in human volunteers.Managed generic DPIs for regulated market including innovator and device characterization and generic prototype development. Show less

Hamdard University, New Delhi

Developed novel formulation designs for chronotherapeutic delivery against hypertension and AR.Developed patentable designs for oral chronotherapeutic delivery of drugsBilayered core inlay tablet designUnitary core compression coating using hydrophobic pore formerTested versatility of designs on other similar drug molecules In vitro characterisation, in vivo pharmacokinetic evaluation, drug radio-labelling and gamma scintigraphy evaluation of drug release site… Show more Developed novel formulation designs for chronotherapeutic delivery against hypertension and AR.Developed patentable designs for oral chronotherapeutic delivery of drugsBilayered core inlay tablet designUnitary core compression coating using hydrophobic pore formerTested versatility of designs on other similar drug molecules In vitro characterisation, in vivo pharmacokinetic evaluation, drug radio-labelling and gamma scintigraphy evaluation of drug release site and pattern on human volunteers (performed at INMAS, DRDO, New Delhi). Show less

Gurgaon, India

Development of non-infringing and patentable products of drugs as ANDAs with bio-equivalent profiles for the advanced regulated markets (US/Europe). Got trained on the following technologies:Geomatrix technologyOsmotic drug deliveryMatrix of diffusion/erosion tabletsMulti-particulate technologyDelayed release for GI targeting

B. Pharm, M. Pharm, Ph.D, (Pharmaceutics)

University Gold Medalist in M. Pharm and B. Pharm

Certificate Course On Intellectual Property Rights, Patents

Higher Secondary, Medical Science