🇬🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Greece

Swissmedic–Compliant DMF / ASMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd

DMF Direct provides end-to-end Drug Master File (DMF) / Active Substance Master File (ASMF) preparation, review, submission, and lifecycle management services specifically tailored for Switzerland’s independent, high-standard regulatory framework.

Our DMF/ASMF services are designed to meet the expectations of:

• Swissmedic – Swiss Agency for Therapeutic Products

• Federal Act on Medicinal Products and Medical Devices (HMG)

And comply with:

• Swiss Therapeutic Products Act (TPA)

• Swiss GMP (aligned with EU GMP & PIC/S)

• ICH Guidelines

• CTD / eCTD dossier formats used for:

• API technical registration & ASMF linkage in Switzerland
• Finished formulation (FPP) product authorization
• Import & Swiss batch certification
• Local MAH & Authorized Representative submissions
• Export-oriented Switzerland regulatory filings

We specialize in the preparation and maintenance of both:

1. Open Part (Applicant’s / MAH Part)

2. Closed Part (Restricted / Confidential Part)

Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with Swissmedic.

Our Core DMF / ASMF Services – Switzerland

🧪 DMF / ASMF Preparation – Open & Closed Parts (Switzerland-Compliant)

We prepare complete, structured, and Swissmedic-aligned ASMF dossiers following CTD/eCTD formats accepted for Swiss national submissions.

Applicant’s Part (Open Part)

Prepared for submission to Swissmedic / Swiss Marketing Authorization Holders (MAHs), including:

• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– Swiss National Drug Authorization
– API Technical File (ASF) linkage
– Import & Local MAH Submissions
• CTD-structured documentation suitable for Switzerland and global regulatory filings

Restricted Part (Closed / Confidential Part)

Secure preparation and controlled handling of proprietary technical information, including:

• Detailed manufacturing process & process validation
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2 + Ph. Eur. / USP as accepted by Swissmedic)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per Swiss climatic conditions (Zone I – Temperate)

✅ Confidential data is disclosed only to Swissmedic assessors — not to MAHs or commercial partners.

DMF / ASMF Types Covered – Switzerland

We support DMF / ASMF documentation for:

• API / Drug Substance (ASMF / ASF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information

🧪 DMF / ASMF Review & Gap Assessment – Switzerland

Already have a DMF / ASMF for Switzerland?

We conduct Switzerland-specific DMF / ASMF review and regulatory risk assessment based on:

• Swissmedic quality assessment expectations
• Swiss GMP & PIC/S compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely Swissmedic deficiency & technical query triggers

✔️ You receive a clear, actionable gap assessment report before Swissmedic submission or inspection.

🧪 Swissmedic Submission & Switzerland Regulatory Support

We provide hands-on support for DMF / ASMF filing and regulatory usage in Switzerland, including:

• Swissmedic electronic & paper submissions
• API technical file linkage
• Finished product registration dossiers
• Import authorization & Swiss QP documentation
• Local MAH & Authorized Representative coordination

Our team ensures:

• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Full consistency across DMF/ASMF, marketing authorization dossiers, and manufacturing records

🧪 DMF / ASMF Lifecycle Management & Maintenance – Switzerland

We manage your DMF / ASMF through its complete regulatory lifecycle, including:

• Initial ASMF compilation
• Annual updates & variations
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• Swissmedic-driven post-approval changes

🧪 Post-Submission Deficiency & Query Handling – Switzerland

Complete post-submission regulatory support, including:

• Swissmedic deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Swiss MAHs & importers
• Coordination between manufacturer, MAH & Swissmedic

🎯 Goal: Faster approvals, fewer queries, and Swissmedic-ready DMF / ASMF documentation.

🧪 Why Choose DMF Direct for Switzerland?

🧪 Deep expertise in Swissmedic regulatory pathways
🧪 Strong experience with Swiss GMP, PIC/S & ICH-aligned ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven Swissmedic deficiency & technical query response success
🧪 Seamless coordination with Swiss MAHs, importers & Authorized Representatives
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength

Industries We Support – Switzerland

• API manufacturers
• Finished formulation (FPP) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• Swiss importers & MAHs
• Contract Manufacturing Organizations (CMOs)
• Export-focused pharma companies

Regulatory Standards Followed – Switzerland

• Swiss Therapeutic Products Act (TPA)
• Swissmedic Regulatory & Quality Guidelines
• Swiss GMP (PIC/S aligned)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• European Pharmacopoeia / USP (as accepted by Swissmedic)
• WHO-GMP (where applicable)

Your Trusted Partner for DMF / ASMF Excellence in Switzerland

Whether you are preparing a new ASMF for Switzerland, updating an existing Swissmedic technical file, supporting a Swiss national product registration, appointing a Swiss MAH & Authorized Representative, or responding to Swissmedic queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the Swiss pharmaceutical market.

✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven

If you want, I can also prepare:

✅ Switzerland–Germany–Austria (DACH) regional ASMF version
✅ SEO landing page for “DMF / ASMF Services for Switzerland”
✅ Export-focused Switzerland DMF services page for Indian API & FDF companies