About
We provide in-depth consulting solutions to drug development challenges and required project management, operations and business scope considering the markets based on a strong foundation of pharmaceutical sciences and current advances in pharmaceutical technologies for formulation development.
Our Team
Our team comprises of experienced scientists and distinguished advisors affiliated earlier with the Industrial and Physical Pharmacy Department, Purdue University, USA and also with Industry.
Dr. Sai Sumana Penumetcha, PhD (USA)
Industrial Pharmacy
Certifications:
Regulatory & Quality Compliance (Purdue)
Capital Markets (NYIF)
Business Analytics (Wharton, UPenn)
Project Management (UCI)
Dr. Penumetcha, founder of Aimhour Pharma has more than a decade experience in R&D from Discovery through Development of Pharmaceuticals for INDs, NDAs and Generics in contract work with Big Pharma at Purdue, in CRO/CMOs in Consultant and Managerial roles Overseeing projects and Operations, and also in Teaching, Research & Postdoctoral roles at Purdue.
Advisory Members
Dr. Kenneth Morris, PhD
Expertise
Our expertise is in consultations for drug development solutions for INDs, NDAs, 505b2 and ANDA projects with the related project management and operations.
Background
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Regulatory and Quality Compliance Certified (Purdue University) with sound know how of Drug and Patent Law and Patent filings as applied in the certificate program and also experience in several R&D projects.
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In contract work within Consortium of Advanced Manufacturing of Pharmaceuticals with GSK, developed Quality Control PAT tools for Tablet Coating that were adapted into FDA guidelines for QbD.
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Led several discovery projects with CROs (SSCI-AMRI) in preformulation/formulation development leading to Preclinical trials for INDs furthering development for an NDA approval.
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Analytical technologies with Synchrotron XRD in fast screening of formulations for Pharma industry at Argonne National Lab.
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Experienced in aseptic processes for Sterile Drug Products in Industry & Clinical practices, Molecular Pharmacology & Medicinal Chemistry research for Drug candidates, Bioanalytical and advanced Material Characterization for Raw materials & Drug products.
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Led ANDA, 505b2 projects in Industry for solid, liquid & sterile dosage forms through exhibit batches & filings for developed, ROW markets with Clinical bioequivalence studies.
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Adept in Combination sterile drug product development and led projects through Technology Transfers with CMOs.
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Dr. Penumetcha was also actively involved with editorial reviews, publications & scientific focus communities of American Association of Pharmaceutical Scientists with prior roles as Vice Chair of Global Health Community, Committee Member of DEI, and Learning Opportunity Managerial roles in Sterile Products Community & Preformulation Drug Design Development Community.