ABOUT
20+
Years of Experience
Sharmi (Sharmistha) Ghosh, PhD
Principal Consultant
Sharmi (Sharmistha) Ghosh, Ph.D. is the founder and principal consultant at Peak BioConsulting with over 20 years of professional experience in drug development. She has held leadership and management positions in small, mid and large innovative companies in the biotechnology and pharmaceutical areas.
Peak BioConsulting has extensive experience in successful submission of marketed products in rare diseases, immuno-oncology, and vaccines. The firm specializes in CMC strategy, analytical and process development, quality control and regulatory submissions for different modalities; recombinant proteins, monoclonal antibodies, ADCs, AAVs, peptides and synthetic oligonucleotides- from preclinical stages through commercialization.
The core competencies are analytical method development, qualification, validation and troubleshooting of process- and product-related impurities, residuals, potency and ID used to define the product quality, safety and efficacy. Additionally, we specialize in design and management of Reference Standard programs, stability and batch release of Drug Substance (DS) and Drug Product (DP), and product lifecycle management.
We have deep understanding with up-to-date knowledge of regulatory requirements across global health authorities and have experience authoring and reviewing successful regulatory filings of INDs, IMPDs, BLAs, and MAAs.
We are GLP and GMP compliant with third-party vendors.
Why Peak BioConsulting?
WHY CHOOSE US?
Unlike traditional bioconsulting firms that offer generalized support, our firm is led by seasoned biopharmaceutical experts with years of hands-on experience in CMC development, analytical strategy, and global regulatory submissions. We specialize in bridging the gap between technical execution and strategic regulatory alignment—ensuring that your drug development program is not only scientifically sound but also submission-ready.
WHAT SETS US APART
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Executive-Level Insight: We bring leadership-level thinking to every engagement, helping clients anticipate regulatory expectations and avoid costly delays.
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Deep Technical Expertise: From analytical method development to QMS implementation, we offer nuanced, phase-appropriate guidance tailored to your modality and stage.
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Global Perspective: Proven success managing CTLs and CDMOs across North America, Europe, and Asia, with experience in FDA, EMA, and CVM interactions.
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Integrated Approach: We don’t just advise—we embed ourselves in your team to co-create solutions that align science, quality, and strategy.
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Commercial Readiness Focus: Whether you're preparing for your first IND or scaling for BLA submission, we help you build the infrastructure and data package regulators expect.
Our Approach
Discover
Assessing development stage, identifying gaps, and defining a regulatory-ready roadmap
Align
Crafting tailored strategies that bridge technical execution with global regulatory goals
Deliver
Driving efficient execution across CMC, analytical, and quality systems to meet milestones
Elevate
Providing ongoing support to scale operations, ensure compliance, and prepare for growth