You will get detailed FDA consultation for your project
Top Rated
Top Rated
Project details
This is a detailed consultation designed to provide high level FDA regulatory guidance that can help inform an early go or no go decision for your project.
During the discussion, I can cover general compliance expectations, key regulatory requirements, possible pathways to move forward, and how I may be able to support the overall process, including broad timeline expectations.
I have also worked with companies over the past 8 years by sharing practical experience in FDA compliance relevant to regulatory affairs and quality related initiatives. I prefer Zoom or teleconference calls, although teleconferences are usually easier to arrange.
During the discussion, I can cover general compliance expectations, key regulatory requirements, possible pathways to move forward, and how I may be able to support the overall process, including broad timeline expectations.
I have also worked with companies over the past 8 years by sharing practical experience in FDA compliance relevant to regulatory affairs and quality related initiatives. I prefer Zoom or teleconference calls, although teleconferences are usually easier to arrange.
Field of Law
Health & MedicalTarget Country
United StatesLanguage
EnglishService Type
Regulation & ComplianceWhat's included $80
These options are included with the project scope.
$80
- Delivery Time 4 days
29 reviews
(28)
(1)
(0)
(0)
(0)
This project doesn't have any reviews.
WW
Wei Jian W.
Jul 9, 2026
Paid 60-minute discovery call about life sciences regulatory workflows
AM
Aarti M.
Jun 14, 2026
Handheld XRF rental/compliance guidance for India
FW
Felix Sunny W.
Jun 10, 2026
Writer Activation for Pubrella
Abhijath was an excellent freelancer to work with. He provided detailed and actionable feedback on our project. Communication is great, and I would highly recommend him for any client looking into regulatory work
RS
Romi S.
Apr 7, 2026
Drug Regulations
Abhijath supported me on a project related to drug regulations and regulatory intelligence. He was was knowledgeable. Completed the project on time. Good communicator. I will hire him again!
LP
Leena P.
Apr 6, 2026
Key Imperatives for Ensuring Compliant Provision of Unlicensed Medicines Globally
About Abhijath
Regulatory Affairs Consultant (RAPS) USFDA & EMA | Formulation Advisor
100%
Job Success
Kozhikode, India - 1:59 am local time
Past Experience :
- I am having 8+ years of combined experience in Regulatory Affairs + Clinical Research + Medical Affairs - guiding sponsors from first-in-human to post-market.
- I help in formulation of Dietary Supplements in US, EU, India.
- I help biotech and pharma teams design inspection-ready studies, secure ethics approvals, and deliver submissions that move programs forward on time and audit-proof.
- MDR/IVDR support, Clinical Evaluation Reports, Performance Evaluation Reports, and technical file documentation.
- I perform Regulatory gap assessments, audit readiness, health authority response support, and compliance strategy.
Expertise on : USFDA • EMA • CDSCO
I support IND/CTA/NDA submissions, eCTD documentation, labeling compliance, QA workflows, and clinical writing across startups, CROs, and emerging biotech teams. My focus is delivering accurate, inspection‑ready documents that accelerate development timelines without compromising compliance.
What I Deliver :
- IND, CTA, NDA, and ANDA module writing, particularly for CTD Modules 2 to 5.
- Submission Preparation : eCTD support (Modules 1–5)
- Labelling : US Prescribing Information, SmPC, CCDS review, labeling compliance, and content alignment.
- SOP development, QA documentation, CAPA logs
- Regulatory Writing : Clinical writing: Protocols, IBs, CSRs, safety summaries
- Regulatory intelligence & documentation QC
- Variation Preparation & Renewal Analysis (US & EU)
Why Clients Work With Me :
- RAC (US,EU, Global) certified
- Strong foundation in FDA, EMA, HC, and ICH frameworks
- High accuracy, fast turnaround, and structured workflows
- Experience validating regulatory datasets used in AI systems
- Ability to produce submission‑ready content across drugs, biologics, and devices
If you need support preparing a submission, reviewing labeling, drafting SOPs, or QC‑checking regulatory documents, I can step in immediately and deliver with precision.
Send me a message with your project details - I typically respond within a few hours.
Also, If your regulatory documentation needs to be ready for submission and not sent back for repeated revision, share your project brief. I can help turn complex regulatory content into a strong, well-structured submission package.
Keywords : Regulatory Affairs • IND/IDE • 510(k) • SaMD • ICH-GCP • IRB • Clinical Trial Design • Protocol Development • Pharmacovigilance • Medical Writing • CSR • IB • EDC/CRF • EMA • CDSCO • US FDA • 505 b(1) • 505 b(2)
Steps for completing your project
After purchasing the project, send requirements so Abhijath can start the project.
Delivery time starts when Abhijath receives requirements from you.
Abhijath works on your project following the steps below.
Revisions may occur after the delivery date.
Submission
Submission of Document/Information