Regulatory Affairs Associate
Current
Apr 2022 - Present
AeroLeads people directory · profile
Prachi Dave Email & Phone Number
Regulatory Affairs Associate at Freyr Inc.
at
Freyr Solutions
1 work email found
@appcopharma.com
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 86%
Current company
Role
Regulatory Affairs Associate at Freyr Inc.
Location
Iselin, New Jersey, United States
Who is Prachi Dave? Overview
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Quick answer
Prachi Dave is listed as Regulatory Affairs Associate at Freyr Inc. at Freyr Solutions, based in Iselin, New Jersey, United States. AeroLeads shows a work email signal at appcopharma.com and a matched LinkedIn profile for Prachi Dave.
Prachi Dave previously worked as Regulatory Affairs Associate at Freyr Solutions and Regulatory Affairs & Formulation R&D Documentation Associate at Appco Pharma Llc. Prachi Dave holds Master'S Degree, Regulatory Affairs from Northeastern University.
Company email context
Email format at Freyr Solutions
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{first}.{last}@appcopharma.com
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AeroLeads found 1 current-domain work email signal for Prachi Dave. Compare company email patterns before reaching out.
Profile bio
About Prachi Dave
A motivated Regulatory enthusiast pursued Master’s in Regulatory Affairs for Drugs, Biologics and Medical devices. I am punctual, focused and have experience in working as a Regulatory Affairs at Freyr Inc. in United States. Skills:-Regulatory submissions: IND, NDA, eCTD, Clinical Trial Protocol, Informed Consent Form, PMA, 510(k), IDE, FDA form 2253.Regulatory concepts: FDA and ICH regulations, 21 CFR, Regulatory operations and submissions, CMC, Quality control-assurance, Clinical trials, FDA and EU medical device regulations, Post-market surveillance, Product life-cycle management, and GCP, GMP, GLP standards.Technical skills: eCTD submissions, Clinical data analysis, MedDRA.Computer skills: Microsoft Project, MS Excel, MS Word, MS PowerPoint, Microsoft Outlook, SharePoint.Other skills: Leadership, management, effective communication, detail-oriented, Persuasive, Reliable, and Resilient.As an aspiring Regulatory Affairs professional, I am eager to connect with professionals in the healthcare industry. You can reach out to me at prachitdave98@gmail.com or by phone at +1(617)-447-7843.
Current workplace
Prachi Dave's current company
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4 roles
Prachi Dave work experience
A career timeline built from the work history available for this profile.
Regulatory Affairs & Formulation R&D Documentation Associate
- Preparation, review and approval of all documents required for exhibit batches.- Reporting, Tracking and management of incidents, planned deviations, cGMP documentation,change controls and CAPAs.- Compilation and Submission of ANDA documents - Annual Report in eCTD format to FDA.- Generation and Reporting of periodic Adverse Drug Experience Report /.
Oct 2021 - Apr 2022
Regulatory Affairs Intern - Capstone Project
- Full 510(k) submission for COVID-19 device, Negative Pressure SteriDome (NPS) - The NPS is part of original patent to protect patients from external pathogens and protect caregivers and the surrounding environment from infected patients within a controlled microenvironment and is approved by the FDA for Emergency Use Authorization for our negative.
Apr 2021 - Jul 2021
Pharmaceutical Intern
- Established Standard Operating Procedures for drugs and collaborated with the Formulation team for better drug approach and discuss new delivery strategies. - Appraised pharmaceutical equipment’s. Trained on drug manufacturing processes including formulation, labelling, and secondary packing. - Maintain track of Raw Material ingress and External vendors.
May 2018 - Jun 2018
2 education records
Prachi Dave education
Master'S Degree, Regulatory Affairs
Northeastern University
Bachelor Of Pharmacy - Bpharm, Pharmacy
Rk University
FAQ
Frequently asked questions about Prachi Dave
Quick answers generated from the profile data available on this page.
What company does Prachi Dave work for?
Prachi Dave works for Freyr Solutions.
What is Prachi Dave's role at Freyr Solutions?
Prachi Dave is listed as Regulatory Affairs Associate at Freyr Inc. at Freyr Solutions.
What is Prachi Dave's email address?
AeroLeads has found 1 work email signal at @appcopharma.com for Prachi Dave at Freyr Solutions.
Where is Prachi Dave based?
Prachi Dave is based in Iselin, New Jersey, United States while working with Freyr Solutions.
What companies has Prachi Dave worked for?
Prachi Dave has worked for Freyr Solutions, Appco Pharma Llc, Breegi Scientific, Inc., and Acme Diet Care Private Limited.
How can I contact Prachi Dave?
You can use AeroLeads to view verified contact signals for Prachi Dave at Freyr Solutions, including work email, phone, and LinkedIn data when available.
What schools did Prachi Dave attend?
Prachi Dave holds Master'S Degree, Regulatory Affairs from Northeastern University.
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