With a focus on quality, compliance, and timely delivery, we empowers manufacturers and exporters to navigate complex regulatory landscapes with confidence.
Regulatory & Research Services
Zoesoe Exports Pvt Ltd
Zoesoe Exports Pvt Ltd is a trusted partner in the global pharmaceutical and healthcare industry, providing specialized Regulatory Affairs services and Contract Research Organization (CRO) solutions. We support companies in achieving seamless market entry and compliance by delivering comprehensive regulatory documentation, dossier preparation, DMFs, and export registration services across ROW, US, European, and ASEAN markets.
As a CRO, Zoesoe offers end-to-end formulation development and analytical research services, including method validation, bioequivalence study support, and technical documentation as per ICH and country-specific guidelines. Our expertise ensures that every project aligns with international quality standards, helping clients accelerate their product development pipeline while maintaining compliance and scientific integrity.
Guided by our philosophy “Global-Science-Trust,” Zoesoee Exports Pvt Ltd combines regulatory excellence with cutting-edge research to empower manufacturers, exporters, and healthcare innovators worldwide.
Business Support Designed Around You
www.mydossier.in
Regulatory Services for Global market
CTD / eCTD / ACTD Dossier Preparation
Country-Specific Dossier Compilation (ROW / ASEAN / EU / US / GCC / Africa)
Module 1 – Administrative and Product Information
Module 2 – Summaries and Overviews (QOS, QIS, Nonclinical & Clinical Summaries)
Module 3 – Quality (Drug Substance & Drug Product Sections)
Module 4 – Nonclinical Study Reports
Module 5 – Clinical Study Reports
Regulatory Query Response Preparation and Gap Analysis
Labeling, Artwork, and Package Insert Compilation
Common Dossier Template (CDT) for Semi-Regulated Markets
Review and Formatting of Dossier as per Authority Requirements
Electronic Dossier Submission Support and Documentation Training
Tailored to Your Needs
www.zodiacpharma.com
CRO - R&D for Analytical and Formulation
Analytical Method Development and Validation (Assay, RS and Disso)
Forced Degradation and Stability Studies (Accelerated & Long-Term) as per ICH
Formulation Development – Tablets, Capsules, Liquids, Ointments, and Creams
Technology Transfer (TT) and Validation Batches Support
In-vitro Release and Comparative Dissolution and Bioequivalence Studies
Analytical Data Review and Report Preparation (COA, PDR, Validation Reports)
Impurity Profiling and Characterization
www.pdds.in
Pragya Dossier-DMF Services (PDDS India)
Dossier Preparation & Compilation
Drug Master File (DMF) Services
Product Registration Services
Analytical Method Validation (AMV) & Process Validation
Bioequivalence (BE) & Clinical Study Services
Product Development & Technical Documentation
Regulatory Consulting & Compliance
Cosmetics, Herbal & Nutraceutical Regulatory Affairs
Veterinary Regulatory Affairs
Regulatory Training & Documentation Services
Frequently asked questions
What services does Zoesoe Exports Pvt Ltd provide?
We provide Regulatory Affairs services (dossier preparation, DMF compilation, export registration, compliance documentation) and Contract Research Organization (CRO) services (formulation development, analytical method validation, bioequivalence study support, and technical writing).
Which industries do you serve?
We primarily serve the pharmaceutical, herbal, nutraceutical, veterinary, and cosmetic industries, supporting both Indian and international manufacturers and exporters.
Do you provide global regulatory support?
Yes, our team has expertise in ROW, USFDA, EMA (Europe), ASEAN, and other international market (List of countries) guidelines, enabling smooth regulatory approvals and export registrations.
What kind of services do you offer?
At Zoesoe Exports Pvt Ltd, we deliver end-to-end Regulatory Affairs solutions with global compliance expertise:
Dossiers & DMFs (CTD/ACTD/ROW formats)
Bioequivalence (BE) Studies – design & reporting support
Product Development Reports (PDR)
Analytical Method Validation (AMV)
Process & Equipment Validations
Clinical Trial (CT) Reports
Periodic Safety Update Reports (PSUR)
Stability Studies (as per ICH/WHO guidelines)
Process Validation Protocols & Reports
Batch Manufacturing Record (BMR) & Master Formula Record (MFR)
Module 4 & Module 5 (Non-clinical & Clinical data)
Toxicity Reports (OECD/AYUSH/ICH guidelines)
Research Services – Advanced CRO Solutions
Our Contract Research Services support both formulation development and analytical research, ensuring robust product innovation and regulatory compliance.
Formulation R&D
Product Development (PD) – prototype to scale-up
Technology Transfer (TT) – lab to commercial production
Analytical R&D
Analytical Method Validation (AMV)
Assay Development
Dissolution Studies
Related Substances (RS) & Impurity Profiling
How can I contact you?
You can contact us through our website (www.pdds.in and www.mydossier.in and www.zodiacpharma.com) or via email with your project details. Our team will review your requirements and provide a customized solution
