MYDossier.in

Dossier &​ DMF​

for International Registrations

GLOBAL REGULATORY AFFAIRS SERVICES

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Our Story​

Delivering Total Regulatory Solutions with integrity, precision, and trust.

MYDOSSIER​​

MyDossier (Indian Firm) was founded with a clear vision – to simplify regulatory documentation and compliance for Indian manufacturers and exporters.

Where science meets regulation, we deliver global compliance with precision and integrity

Founder

Our Services

“Simplifying Compliance, Accelerating Approvals.”

Dossiers and DMFs

+ CTD / eCTD Dossier Preparation
+ ACTD Dossier Preparation
+ ROW Dossier Preparation
+ Drug Master File (DMF) Preparation – CTD format

CDP and BA/BE

+ Comparative Dissolution Profile (CDP)​
+ Bioequivalence (BE) Study Services (as per country-specific guidelines)

Clinical and Toxicity Report

+ Clinical Trial Report (CTR) Writing
+ Toxicity Report Writing

Validation & Analytical Services

+ Analytical Method Validation (AMV) – as per ICH
+ Process Validation
+ Stability Studies Documentation

Consultancy​

+ Training in Dossier & DMF Preparation (CTD / ACTD formats)
+ Regulatory Affairs Consultancy
+ Export Regulatory Support up to Registration

Technology / Transfer

+ Batch Manufacturing Record Preparation
+ Master Formula Record Preparation
+ Module 3 (Quality – CMC) Documentation for APIs & Formulations
+ Manufacturing Process Descriptions & Process Controls

“Connect with us – share your inquiry, we’ll guide the rest.”​

“Where Documentation Meets Global Standards.”

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“Reach Out. We’re Here to Support Your Growth.”

“Let’s Connect for Compliance.”

Contact

+91 85000 72200
(Meet us at Mumbai, Bangalore, Delhi, Jodhpur, Hyderabad)

Email

info@mydossier.in
Hours – Monday – Friday: 9:00 – 18:00 Saturday: 9:00 – 16:00 Sunday: Closed

​Head Office

Plot No. 63, 76 and 77 APIIC Industrial Park, NH42 Madanapalle, Andhra Pradesh 517325, India

Frequently Asked Questions (FAQs) – MYDOSSIER

1. What is MYDOSSIER?
MYDOSSIER is a regulatory affairs documentation service platform that supports Indian startups, MSMEs, and manufacturers in preparing dossiers, DMFs, and regulatory submissions for pharmaceuticals, nutraceuticals, herbal, veterinary, and cosmetic products.

2. What services does MYDOSSIER provide?
We provide comprehensive documentation and regulatory solutions, including:
Dossiers (CTD, ACTD, ROW formats)
Drug Master Files (DMFs)
Bioequivalence (BE) Studies documentation
Product Development Reports (PDR)
Analytical Method Validation (AMV)
Comparative Dissolution Profile (CDP)
Process & Cleaning Validations
Clinical Trial Reports (CTR)
Periodic Safety Update Reports (PSUR)
Stability Studies
Batch Manufacturing Records (BMR & MFR)
Toxicology Reports & Safety Data Sheets (SDS)

3. Who can use MYDOSSIER services?
Startups & MSMEs in pharma, nutraceutical, herbal, veterinary, and cosmetic sectors.
Contract manufacturers & exporters needing regulatory submissions.
Healthcare product innovators seeking global compliance.

4. Do you prepare dossiers for global submissions?
Yes ✅. We prepare dossiers for US, EU, ASEAN, and ROW markets in line with international regulatory guidelines.

5. Can MYDOSSIER help with DMF preparation?
Yes. We specialize in Drug Master File (DMF) preparation in CTD format, ensuring compliance with international regulatory authorities.

6. Do you also provide training?
Yes. MYDOSSIER offers training services in:
Dossier preparation (CTD/ACTD)
DMF compilation
Regulatory documentation best practices

7. What makes MYDOSSIER different?
Expertise in complete regulatory documentation
Tailored support for Indian startups and MSMEs
End-to-end solutions from dossier writing to global submission
Strong focus on quality, compliance, and accuracy

8. Do you provide only documents or end-to-end consultancy?
We provide both ✅. MYDOSSIER not only prepares documents but also offers regulatory guidance, compliance support, and advisory services for successful product registration.

9. How can I get started with MYDOSSIER?
You can contact us via:
📧 info@mydossier.in
📞 +91 85000 72200
Our experts will analyze your requirements and provide a customized service plan.

10. Do you cover non-pharma sectors too?
Yes. Along with pharmaceuticals, we also provide documentation for herbal, nutraceutical, veterinary, and cosmetic exports.