Drug Development
Support at Every Stage
Over 50 years of experience in removing barriers and accelerating drug development through tailored strategic, technical, Quality and Regulatory support.
SERVICES
Hands-On Support Every Step of the Way
Our Team.
Nayaz Ahmed, PhD, RAC (US, EU), CQA, Six Sigma Green Belt
Founder & Principal
Nayaz Ahmed brings 25 years of expertise in pharma, biotech, and medical devices, spearheading small molecule, peptide, protein, and plasmid-based drug development from concept to commercialization. With a PhD in Organic Chemistry and certifications in RAC (US, EU), CQA, and Six Sigma, he founded Indigo Life Science (formerly CQPS) to deliver innovative CMC and quality solutions. Passionate and dedicated, Nayaz excels at aligning teams to meet FDA, EU, ICH, and ISO standards, guiding inspections, and driving regulatory excellence.
Uma Lakshmipathy, PhD
Scientific Advisor & Founding Visionary
Uma Lakshmipathy offers 25+ years in R&D—spanning corneal stroma proteins, stem cells, and cell/gene therapy—as Site Head for Thermo Fisher Scientific’s Cell and Gene Therapy Division. A 2025 ISSCR Public Service Award Honoree with numerous patents and publications, she advises scientific boards, including paid SAB roles, shaping industry innovation. Uma lends strategic insight to Indigo Life Science, amplifying its mission with her expertise and shared passion for impactful work.
Our Combined Impact
Together, Nayaz and Uma unite over 50 years of experience, 10+ patents, and 100+ publications, blending CMC, quality, and cell/gene therapy leadership to advance innovative solutions across pharma, biotech, and medical devices. For them, work is a lifelong passion, fueling happiness and excellence.
Disclaimer: Drug approval contributions reflect Nayaz Ahmed’s consulting support to CDMOs and clients for CMC and quality activities, not direct sponsorship by Indigo Life Science. Uma Lakshmipathy’s role is limited to strategic scientific guidance, consistent with her Thermo Fisher Scientific-approved SAB activities, and does not involve active consulting for Indigo clients
Services
Strategy
Providing strategic support including: landscape analysis, technical and regulatory literature review and grant and manuscript writing
Innovation
Performing platform and technical evaluations, development of research plans, and support for scientific collaborations and meetings
Research and Development
Supporting the design and development along the entire product development process.
Regulation and Quality
Design, development, and Implementation of comprehensive QMS systems to include SOP, Protocols, CAPA, OOT, OOS, FMEA
QbD-based Pharmaceutical Development
Support from concept to commercialization for plasmid vaccines/oncology, injectables, sterile ophthalmic, nasal, oral, medical devices, and cosmetics products
Analytical Method Development
Support for validation, transfer, and USP verification, including environmental monitoring, microbial controls, raw material testing, compendial testing, in-process testing, release, and stability testing of plasmids, and biological life cycle management.
Documentation
Support with preparation of CMC Dossier for IND/NDA/ BLA/ANDA/PMA. PA inspections, remediation of CMC issues- FDA 483, Notice of Observations, and Warning Letter
Training
Curriculum development for technical, quality, and regulatory focused topics, tailor-made for expertise level for both academia and industry.
Track Record of Success
50+
Years of Experience
100+
Papers Published
10+
Drugs Approved
10+
Patents
