Consultant
Current
2013 - Present
~13 yrs 4 mos
AeroLeads people directory · profile
Nancy Harper Email & Phone Number
Consultant at Pharmaceutical Advisors LLC and Design Space Inpharmatics
at
Pharmaceutical Advisors LLC
1 work email found
@pharmadvisors.com
2 phones found area 860
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Consultant at Pharmaceutical Advisors LLC and Design Space Inpharmatics
Location
Greater Boston, United States, United States
Company size
Who is Nancy Harper? Overview
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Quick answer
Nancy Harper is listed as Consultant at Pharmaceutical Advisors LLC and Design Space Inpharmatics at Pharmaceutical Advisors LLC, a company with 10 employees, based in Greater Boston, United States, United States. AeroLeads shows a work email signal at pharmadvisors.com, phone signal with area code 860, and a matched LinkedIn profile for Nancy Harper.
Nancy Harper previously worked as Consultant at Pharmaceutical Advisors Llc and Senior Drug Product Consultant at Dsi - Design Space Inpharmatics Llc. Nancy Harper holds Phd, Pharmaceutics from The University Of Connecticut.
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{first}.{last}@pharmadvisors.com
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Profile bio
About Nancy Harper
Accomplished pharmaceutical product development scientist with emphasis on development of parenteral, oral liquid and inhalation products. Unique talent for merging scientific rigor, regulatory expertise, and pragmatism into drug product development while ensuring that customer needs are met. Expert in commercial drug product design and development, application of Quality by Design (QbD) concepts, CMC regulatory strategy/authorship, technical risk assessment and problem solving. Key contributor as formulator or pharmaceutical expert to the development and successful commercialization of 10 new drug products. Experience with NCE’s (human and veterinary), product enhancements, and generic products for developed and emerging markets.Specialties: Formulation design and development, Technical risk assessment, Process development and scale-up , Technical due diligence for business development, CMC regulatory strategy, Data analysis and interpretation, CMC submission component authorship, Life cycle management
Listed skills include Regulatory Submissions, Formulation, Technology Transfer, Pharmaceutics, and 25 others.
Current workplace
Nancy Harper's current company
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Pharmaceutical Advisors Llc
7 roles · 13 years
Nancy Harper work experience
A career timeline built from the work history available for this profile.
Senior Drug Product Consultant
Current
Sep 2016 - Present
Pharmaceutical Consultant
Current
Harper Pharmaceutical Consulting Llc
Nov 2011 - Present
Consultant
Nov 2011 - Jun 2017
Research Fellow, Life Cycle Management
- Developed a streamlined product development process incorporating QbD principles based on ICH Q8, Q9, Q10, adaptable to the needs of fast-paced generic and product enhancement projects. As part of this process.
- Delivered a variety of in-house training sessions on the CTD P2 section, and concepts of QbD.
- Identified new product enhancement opportunities for established products and emerging markets business units leading to initiation of six projects (6-month depot injection, multi-dose IV, IV lyophile with improved.
- Designed lab feasibility studies to demonstrate technical viability of several new product concepts for established products and emerging markets business units.
- Provided strategic and technical consultation on product development and regulatory submissions for numerous generic and 505(b)(2) parenteral projects at internal and external development sites, including critical and.
- Performed technical due diligence for seven product licensing and portfolio acquisition opportunities (parenteral and topical dosage forms).
May 2010 - Nov 2011
Research Fellow, Parenteral Center Of Emphasis
- Authored (P1, P2, P3 sections) and served as critical reviewer of all other Module 3 sections of the Exubera CTD, numerous query responses, and participated in various agency meetings as technical expert on both device.
- Provided extensive technical consulting (product development approaches and strategy as well as critical dossier reviews) on multiple parenteral projects in Established Products Business Unit.
- Created and led the Topical Product Development group (4 direct reports), including creation of a topical/ transdermal product development lab.
- Facilitated technical risk assessments on product and process design for several development projects.
- Established a broad program for nurturing scientific excellence in the department.
Jan 2004 - May 2010
Research Sci/Mgr/Asst Director, Liquid Product Development
- Led two joint R&D teams in Nektar partnership on Exubera® (inhaled insulin DPI): drug product and inhaler performance and robustness characterization.
- Developed an IV/IVc for Exubera, enabling identification of the clinically relevant aerosol quality attributes (critical and non-critical), allowing a unique and commercially manageable approach to aerosol.
- Designed comprehensive performance characterization programs for the Exubera inhaler and drug product, including strategy definition, experimental designs, and data analysis/interpretation for the more complex and.
- Managed the Liquids Technology Transfer group (4 senior scientists)
- Pharmaceutical Expert and Expert Report author for three European Marketing Authorisation submissions (Zoloft Oral Concentrate, Geodon IM, Advocin 180 Injection).
- Formulator and Pharmaceutical Expert leading to commercialization of several liquid and parenteral products: Dectomax Pour-On, Zoloft Oral Concentrate, Geodon IM, Advocin Injection, Trovan IV
Nov 1983 - Jan 2004
2 education records
Nancy Harper education
Phd, Pharmaceutics
Bs, Pharmacy
Philadelphia College Of Pharmacy & Sciences
FAQ
Frequently asked questions about Nancy Harper
Quick answers generated from the profile data available on this page.
What company does Nancy Harper work for?
Nancy Harper works for Pharmaceutical Advisors LLC.
What is Nancy Harper's role at Pharmaceutical Advisors LLC?
Nancy Harper is listed as Consultant at Pharmaceutical Advisors LLC and Design Space Inpharmatics at Pharmaceutical Advisors LLC.
What is Nancy Harper's email address?
AeroLeads has found 1 work email signal at @pharmadvisors.com for Nancy Harper at Pharmaceutical Advisors LLC.
What is Nancy Harper's phone number?
AeroLeads has found 2 phone signal(s) with area code 860 for Nancy Harper at Pharmaceutical Advisors LLC.
Where is Nancy Harper based?
Nancy Harper is based in Greater Boston, United States, United States while working with Pharmaceutical Advisors LLC.
What companies has Nancy Harper worked for?
Nancy Harper has worked for Pharmaceutical Advisors Llc, Dsi - Design Space Inpharmatics Llc, Harper Pharmaceutical Consulting Llc, First Aid Shot Therapy, and Pfizer.
Who are Nancy Harper's colleagues at Pharmaceutical Advisors LLC?
Nancy Harper's colleagues at Pharmaceutical Advisors LLC include Paul Woitach.
How can I contact Nancy Harper?
You can use AeroLeads to view verified contact signals for Nancy Harper at Pharmaceutical Advisors LLC, including work email, phone, and LinkedIn data when available.
What schools did Nancy Harper attend?
Nancy Harper holds Phd, Pharmaceutics from The University Of Connecticut.
What skills is Nancy Harper known for?
Nancy Harper is listed with skills including Regulatory Submissions, Formulation, Technology Transfer, Pharmaceutics, Drug Development, Pharmaceutical Industry, R&D, and Gmp.
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