Manish S.
Director @Dms Solutions Ltd
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WORK HISTORY
Director @Dms Solutions Ltd
GB
Working as a Global CMC lead with an independent consultancy based in UK on a contract basis on projects such as MAA\'s, Change Control Assessment, Variations, Renewals, Source transfer applications, etc.Extensive project management which includes developing, executing and maintaining submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.Develop effective regulatory CMC strategies for global submissions from development through commercialization in Respiratory and Pain products category.
EDUCATION
School of Pharmacy, University of London
MSc. Drug Discovery, Drug Disvovery
Sinhgad Institute of Pharmaceutical Sciences
Bachelor of Pharmacy, Pharmaceutical Sciences
St. Francis Xaviers High School
Secondary School Certificate
SKILLS
ABOUT MANISH S.
More than 13 years experience working in pharmaceutical/biotech sector providing CMC and Global Reg Strategy Services to clients in UK/USA/Europe.My expertise includes: Regulatory Submissions (IND, NDA, BLA, MAA, ANDA, DMF, IMPD) – Expertise in writing and reviewing CMC sections (Module 3, QOS, QP declarations). Global Regulatory Compliance (FDA, EMA, MHRA, PMDA, TGA, NMPA) – Good understanding of regional variations in CMC requirements. CMC Strategy & Gap Analysis – Expertise in identifying deficiencies and mitigating regulatory risks. Post-Approval Changes & Lifecycle Management – Hands on experience handling variations, supplements, PAS, annual reports, and change controls. Manufacturing & Tech Transfer Support – Collaborating with CDMOs, ensuring GMP compliance, scale- up, and validation. Biologics/Small Molecules – Specialized knowledge of different product types and their unique regulatory pathways Global regulatory strategy and health authority interactions – Experience working a global regulatory lead and managing health authority interactions (Scientific Advice, FDA meetings)Key Benefits of working with me: Faster Regulatory Approvals – Reduce submission review time by ensuring high-quality documentation. Regulatory Risk Reduction – Avoid refusals or major deficiencies with proactive compliance strategies. Cost Savings – Minimize delays, reduce regulatory rework, and optimize manufacturing approvals. Flexible, Expert Support – No need for a full-time hire - get specialized expertise on demand.No project is too small - I’m here to provide flexible, high-quality support tailored to your specific needs. If you or your team has upcoming CMC regulatory needs, I’d love to discuss how I can assist. Please feel free to message me here and I will respond to you query as soon as I can.
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