Nirav Shah, Pmp Email & Phone Number

Ahmedabad, Gujarat, India

- I am working as CMC specialist for global clients for product life cycle management, gap analysis, CMC module drafting and review.- Accountable for the CMC technical work as well as CMC project management/coordination- Formulating the worldwide regulatory CMC strategy for the development, licensure, and maintenance of pharmaceutical products- Represent CMC regulatory team on project and process cross-departmental/functions teams and provide unified/aligned CMC regulatory strategic advice and project regulatory status.- Identify product CMC regulatory risks and propose mitigation strategies, escalating as necessary- Dossier due diligence and Gap analysis- Encourage continuous improvement within the boundaries of regulatory compliance.- Drafting and review of the module 3, module 2.3 dossier documents. - Understand and apply knowledge of ICH and FDA, EMA guidelines, GMP, and quality requirements toward regulatory strategy and product development, licensure, and maintenance.- Participate in health authorities’ interactions/responses- Interface and represent GRA with/to external partners & teams (both external to GRA ( Quality and Supply functions) and external) to ensure global dossier alignment and support supply and enable the commercial success of our partners.- Responsible for Continuous Professional Development to maintain up-to-date knowledge of new Regulatory requirements as well as technical developments relevant to my area of expertise and proactively share knowledge for the benefit of others.- Authoring and implementation of regulatory Policies & Standard Operating Procedures- Ensure an efficient and transparent working environment within the CMC team.- Oversee all the technical aspects of formulation development and analytical development- On-site and off-site technical support for technology transfer activities and formulation development R&D activities- Preparation of the variation packages, IMPD preparation, and other CMC-related work

Ahmedabad, Gujarat, India

Planning and prioritizing the projects based on the strategic business objectives and organizational goalsResponsible and accountable for the preparation of project plan, budget, resources allotment, project timeline, and tracking plan as a part of project managementCoordination and planning for licensing activities, reference product & raw material procurement, analytical material procurement, and any other logistic support for project initiationProject review plan preparation, risk assessment, and risk management through various methodologiesLed multiple projects, and managed multiple CROs and clients as a project manager.Competent in project management software like Zoho, Microsoft Projects, Efficy, and AlfrescoDeveloping relationships with stakeholders, and keeping them interested and involved in the project. Project management of BE/clinical/non-clinical projects, formulation development projects, technology transfer/site transfer, and CMC projectsReprioritize activities to stay focused on project objectives in changing eventsAnticipate potential conflicting situations for proactive solutions and management to achieve win-win outcomesAbility to work under pressure and manage multiple deliverables at the same timeAn empathetic leader with the ability to connect with a diversified teamMotivating and coaching the team members and identifying tools and strategies to improve and optimize the ways of working and working conditions to achieve high performance and to obtain engagement and retention.

Ahmedabad, Gujarat, India

I managed a team of 4 formulation scientist for the formulation and development generic products for US generic market. Successfully managed a portfolio of more than 10 products at once.Formulation development of highly variable drug molecules, low dose formulations, First to Market (FTM), First to file (FTF) product, and early-FTF productSuccessful transfer of Lab-scale formulation development to validation batch manufacturingImplementation of various product development strategies to match quality attributes of the productDocumentationEffective handling of quarries (IR, DRL & CR) from USFDADrafting and review of the Scale up batch manufacturing protocol/report, CTD module 3 documents, Exhibit batch BMR/BPR etc. Laboratory management and Inventory management. Motivating team, resolution of the internal conflict to meet the goal set by the organizationSkills acquired: Formulation development, technology transfer, team management, project management, CMC/CTD documentation

Ahmedabad, Gujarat, India

Managed a team of 2-4 formulation development scientist. Formulation development of various complex molecules (IR and MR) for US, Canada & EU markets.Actively involved in the setup of new Formulation R&D center and R&D warehouse at AhmedabadIQ, OQ, and PQ of formulation laboratory equipment and instrumentHandling of multiple projects with adequate Strategic Managementi have worked on the formulation development and process optimization of the ER dosage form (Tablets, Pellets), Tab and Pellets in Capsule dosage form, Mini Tab in Capsule dosage formScale-up and Exhibit batch manufacturing of Wurster Process, Bilayer tablet dosage Form, Mini tablets, etc.Hands-on Critical Molecules and production level equipment Inventory and laboratory managementReview of pharmaceutical documentation (BMR, PDR, SOP, module 3.2.P.2 etc.)Compilation of Raw data, Project tracker, evaluation, and contribution of Analytical results and provide input for the selection of new experiment.Actively participate in the team meeting, projects discussion. Number of products developed: 07Project Management:In addition to formulation development responsibilites, i was responsible for Identification and evaluation of new product opportunities for bringing innovative product rangeRegularly and properly updating of project management databaseCoordination and cooperation with other departments for project deliveryEvaluating the market demand for newer combination projectsSkills acquired: Team management, project management, complex product development, R&D setup, equipment installation, Documentation

Ahmedabad, Gujarat, India

I was responsible and accountable for the formulation development of Hormonal products, Non-Hormonal Products for US and EU market.Formulation & Process Optimization for Low dose molecule for better uniformity dosage units.Project Handled: IR Dosage form (Hormonal & Non-Hormonal), Tab in Tab Dosage formI have worked on Para IV, Para II, and FTF molecules. Successfully executed one project for FTF project in a very short period of time.Scale-up and Exhibit Batch manufactured of various Hormonal moleculesTroubleshooting of process at production scale. Reformulation for ease of manufacturing, dissolution enhancement.Strategy discussion for formulation development and submission of P-IV molecule.Laboratory management and Inventory management Skills acquired: low dose formulation, hormonal formulation development, documentation

Ahmedabad, Gujarat, India

I have worked on the formulation development and technology transfer of the Hybrid formulations/505 (b)2 for EU and US market for EU and US based top-10 MNC pharmaceutical firms. Day to day coordination with the other supportive departments for smooth functioning of the project executionExperienced in Formulation Development of MUPS, Bilayer tablet dosage form, for Immediate Release formulations for the US market Stability Improvement of strongly incompatible molecules in bilayer dosage form and monolithic dosage forms also.Hands-on various Critical molecules, processes, and equipment (Bilayer tablet compression machine, Wurster process, roller compaction etc.)Biweekly call with the client for the project update and discussion.Skills acquired: Hybrid formulation, stability enhancement of incompatible molecules, Project management, Customer centricity approach

Ahmedabad, Gujarat, India

As an NDDS scientist, I have worked on the formulation development, clinical batch manufacturing and CTD documentation of NCE molecules for Phase-I,II and II studies. Oral and injectable dosage form formulation development and Optimization of New chemical entity for US and India market.Extensively worked on the preclinical formulation and development of various NCE moleculesHands-on Lipid based dosage form, Solid dispersion for solubility enhancement of the poorly soluble drugsFormulation and Development of Complex molecules (BCS Class II and IV Molecule) for Bioavailability and Stability EnhancementLiterature search on formulation development of NCE dosage forms for clinical studiesEvaluation of clinical and preclinical study resultsCTD Module 3 preparation for IND submissionSkills acquired: Clinical batch manufacturing, CTD documentation, NCE formulation development, Preclinical formulation development, Solubility enhancement techniques, Literature search

Postgraduate Degree, Pharmaceutical Management

M.Pharm- Pharmaceutical Technology, Pharmaceutical Sciences