Nitisha Pyndiah, Ph.D.
Your Biologics Consultant
How Can I Help You?
As a Consultant for HartmannWillner, Nitisha provides you with technical and strategic support for the development of biologics, biosimilars, and biologic/device combination products during preclinical and clinical development and throughout the product lifecycle.
Since joining the company in 2016, Nitisha has helped more than 15 companies with their biologic product development.
Her CMC expertise and experience with biologics, biosimilars (biosimilarity assessment) and interchangeable products will allow you to confidently submit the required analytical and functional analysis of your product to the FDA. Nitisha can also assist you with immunogenicity risk assessment and mitigation.
She has been involved in technical, strategic, and operational regulatory affairs of novel and biosimilar recombinant proteins, monoclonal antibodies, cell therapy, gene therapy, peptides and vaccines. Nitisha has also interacted both with the EMA and the FDA (CDER, CBER, and CDRH).
FDA released a guidance on
interchangeability earlier this
year, is your company ready?
In the last decade, there has been an emergence of
cutting-edge technologies used to discover or create
promising biological products. This ever-evolving field
requires rapidly adapting measures to allow new therapies
to reach patients while ensuring safety and efficacy.
Frequently Asked Questions
What are your qualifications?
- BSc in Biochemistry from the University of Strasbourg (France)
- MSc in Medical Molecular Biology from the University of Westminster (UK)
- PhD in Microbiology with a focus on antiviral proteins and HIV from the University of Lausanne (Switzerland)
- Awarded a Distinction for her MSc and obtained a Young Investigator Award from the Conference on Retroviruses and Opportunistic Infections (CROI) during her PhD
- An active member of the Regulatory Affairs Professional Society (RAPS), the American Association of Pharmaceutical Scientists (AAPS) and the Drug Information Association (DIA, PDA).
- Regulatory affairs certificate in Pharmaceuticals from the RAPS
- Nitisha regularly attends RAPS chapter meetings and conferences with industry and FDA representatives
- Nitisha is currently preparing for her Regulatory Affairs Certification (RAC)
How many years of experience do you have?
Nitisha has over 7 years of experience in biomedical research, biotechnology, clinical studies and regulatory affairs as a biologics consultant. Her experience was gained in international reputed institutions and through projects for major pharmaceutical companies.
What are your areas of expertise in biologics consulting services?
- Monoclonal antibodies
- Recombinant proteins
- Combination products
- Cell therapy
- Gene therapy
- New technologies
- Microbiology, Virology, Molecular biology and Immunology
- Immunogenicity risk assessments and mitigation
- Quality control
- Quality assurance
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
What are your areas of expertise in regulatory processes and requirements?
- Chemistry Manufacturing and Controls (CMC) review from very early product development to late stages
- Scientific and regulatory gap analyses of Investigational Drug Applications (INDs) and Biologics License Applications (BLAs)
- Preparation of Quality Overall Summaries (QOS)
- Preparation of Module 1 and Module 3 documents
- Preparation and support for FDA meetings
- Review and submission of expedited safety adverse event reporting
- Orphan Drug Designations
- Preclinical studies
- Clinical trials
- Pediatric regulations for the EMA and FDA
How do you keep up with new regulations and new technologies?
- Active involvement in RAPS and AAPS communities
- Regular participation at FDA events and conferences joining both industry and FDA representatives
- Participated in the CASSS DC discussion group
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