Pharmaceutical companies across 35+ countries trust Regulatory Overseas for their most critical documentation needs.
★★★★★
"Regulatory Overseas prepared our complete CTD dossier for African markets in record time. Their team's expertise in Module 3 quality documentation was exceptional. We got approval in Nigeria within 8 months — far better than our expectations."
MK
Mohammed K.
Director — Pharma Export Division, India
★★★★★
"We needed ACTD dossiers for three products registered in Myanmar and Cambodia simultaneously. Regulatory Overseas managed all three with a single dedicated manager. Highly professional, transparent, and always responsive."
SA
Sunita A.
Regulatory Head — Generic Pharma Company
★★★★★
"Their COPP and export documentation service saved us weeks of effort. The team knows exactly what each country's health authority expects, and they delivered everything correctly on the first attempt. Absolutely recommended."
AR
Arjun R.
CEO — Tablet Manufacturer, Ahmedabad
★★★★★
"Regulatory Overseas helped us with our Sugam portal application and NOC documentation in Gujarat. They handled all the government portal complexities flawlessly. I've worked with other consultants before, but none match this team's efficiency."
PJ
Priya J.
Managing Partner — Herbal Products Company
★★★★★
"We used their third-party manufacturer sourcing service and were impressed. They found us a GMP-certified suppository and pessary manufacturer in India within two weeks. Their network is vast and their vetting process is thorough."
FK
Fatima K.
Procurement Director — Kenya Pharma Importer
★★★★★
"Outstanding quality of BMR and SOP documentation. Every document was GMP-compliant and audit-ready. When we had a WHO pre-qualification audit, inspectors specifically complimented the quality of our documentation — all prepared by Regulatory Overseas."
RM
Rajan M.
QA Manager — Injection Manufacturer
❓ Frequently Asked Questions
Everything You Need to Know
Answers to common questions about pharmaceutical regulatory documentation, dossier preparation, and our services.
A Common Technical Document (CTD) is an internationally harmonized format for pharmaceutical product registration applications. It is required by regulatory authorities in ICH member regions (EU, US, Japan, Canada, Australia) and many other countries. The CTD is organized into 5 modules: Module 1 (Regional Administrative), Module 2 (Summaries), Module 3 (Quality), Module 4 (Non-clinical), and Module 5 (Clinical).
The ACTD (ASEAN Common Technical Document) is a regional adaptation of the ICH CTD format used specifically for product registrations in ASEAN member countries (Malaysia, Thailand, Philippines, Vietnam, Indonesia, Myanmar, Cambodia, Laos, Brunei, Singapore). While CTD has 5 modules, ACTD has 4 parts: Part I (Administrative), Part II (Quality), Part III (Non-clinical), and Part IV (Clinical).
COPP (Certificate of Pharmaceutical Product) is an official document issued by CDSCO (India's drug regulatory authority) that certifies a pharmaceutical product is authorized for sale in India. It is typically required for product registration in importing countries as proof that the product meets Indian regulatory standards. COPP is issued in the WHO format and may require notarization and apostille for some countries.
Sugam is the online portal of CDSCO (Central Drugs Standard Control Organization) of India for submitting various drug regulatory applications. It covers new drug applications (NDA), import licenses, manufacturing licenses, loan license applications, clinical trial applications, and other regulatory submissions. Our team provides expert guidance and hands-on assistance for all Sugam portal applications.
NOC (No Objection Certificate) in the pharmaceutical context refers to the certificate issued by the state drug licensing authority (FDA Gujarat) for various activities such as loan licensing, expansion of manufacturing scope, or permission for specific manufacturing activities. Regulatory Overseas prepares and files complete NOC applications with the FDA Gujarat office, handling all documentation and follow-up on your behalf.
The timeline for CTD dossier preparation depends on the completeness of data provided and the complexity of the product. Typically, a complete CTD for a generic pharmaceutical product takes 4–8 weeks from receipt of all required data. For products with complex formulations or limited existing data, it may take longer. We provide an estimated timeline during the initial consultation after reviewing your documents.
We provide regulatory documentation services for pharmaceutical product registrations in 35+ countries across Africa (Nigeria, Kenya, Ghana, Tanzania, Ethiopia), Middle East (UAE, Saudi Arabia, Kuwait, Qatar), Southeast Asia (Myanmar, Cambodia, Vietnam, Philippines), CIS Countries (Uzbekistan, Kazakhstan, Kyrgyzstan), and Latin America. Contact us for specific country requirements and we will advise on documentation needs.
To begin CTD dossier preparation, we typically require: Manufacturing License, GMP Certificate, Drug Master File (API), CoA of API and excipients, Finished Product Specifications, Manufacturing Process and Batch Records, Stability Study Data, Analytical Method Validation Reports, Bioequivalence/Bioavailability Study Data (if applicable), and Product Literature from the Reference Product. We provide a detailed checklist during consultation.
Yes, we provide comprehensive pharmaceutical export documentation services including Free Sale Certificate (FSC), GMP Certificate from CDSCO, Certificate of Pharmaceutical Product (COPP), Product Testing Certificate, Phytosanitary Certificate coordination, Notarization and Apostille, and country-specific documentation required by importing health authorities. We coordinate with CDSCO and state drug authorities for all official certificates.
Yes, our manufacturer sourcing service helps you find GMP-certified contract manufacturing organizations (CMOs) in India for specific dosage forms including tablets, capsules, injections, oral liquids, creams, ointments, suppositories, pessaries, and more. We vet manufacturers for GMP compliance, capacity, export track record, and product-specific capabilities before shortlisting.
A Site Master File (SMF) is a document providing specific and factual information about the GMP activities and operations carried out at a pharmaceutical manufacturing site. It is required for WHO pre-qualification inspections, EU GMP audits, and increasingly for regulatory submissions in Africa, Middle East, and Asian markets. Our team prepares SMFs compliant with WHO and PIC/S requirements.
Yes, handling regulatory queries is a core part of our service. When a health authority raises technical, clinical, or quality-related queries on a submitted dossier, our regulatory team prepares comprehensive, scientifically justified responses and supplementary documentation. We have experience with queries from health authorities in Nigeria (NAFDAC), Kenya (PPB), UAE (MoH), Saudi Arabia (SFDA), and many other markets.
BMR (Batch Manufacturing Record) is a step-by-step document recording all activities during the manufacture of a specific batch of a product. BPR (Batch Packaging Record) documents all packaging operations for a batch. MFR (Master Formula Record) is the master template from which BMRs are generated, containing the full formulation, process, and in-process controls. All three are mandatory GMP documents prepared per Schedule M of the Drugs and Cosmetics Act.
Absolute confidentiality is one of our core commitments. All clients sign a comprehensive Non-Disclosure Agreement (NDA) before sharing any data. Your formulations, manufacturing processes, business information, and regulatory strategies are kept strictly confidential. We maintain secure document management systems and only authorized team members have access to project-specific data.
A regulatory gap analysis is a pre-submission assessment that compares your existing product documentation against the requirements of the target country's regulatory authority. It identifies missing data, incomplete studies, or non-compliant documents that would cause a dossier rejection. We offer this as a standalone service before dossier preparation to prevent costly delays and rejections during submission.
Yes, we prepare comprehensive Quality Manuals covering QMS (Quality Management System) framework, organizational structure, quality policies, and GMP commitments. We also develop department-specific SOPs for production, QC, QA, warehouse, engineering, and regulatory departments. All documents are prepared to WHO GMP, Schedule M, EU GMP, and ISO standards as applicable to your facility.
Getting started is simple. Contact us via WhatsApp or email to schedule a free initial consultation. During this call, our regulatory expert will understand your product, target markets, and documentation needs. We then provide a detailed scope of work, timeline, and fixed-fee quotation. Once agreed, we initiate the project with a signed agreement and begin the document collection process.
Step 1 and Step 2 Documentation refer to the phased documentation requirements in certain African and Middle Eastern countries that follow a two-step regulatory review process. Step 1 typically includes administrative and product summary documents, while Step 2 requires the complete technical dossier. Countries like Ethiopia, Tanzania, and some others use this phased approach. We prepare country-specific documentation for each step.
Yes, we handle Product Permission documentation — including applications for permission to manufacture new products at existing licensed facilities in India. This involves preparation of the complete product-specific dossier for CDSCO (for new drugs) or state FDA (for known drugs), including stability data, process validation, and quality specifications. We also assist with import permission documentation for foreign pharmaceutical products.
India is one of the world's largest pharmaceutical exporters, with manufacturing facilities meeting WHO GMP, US FDA, EU GMP, and UK MHRA standards. Indian pharmaceutical companies are uniquely positioned to supply affordable, high-quality generic medicines to emerging markets. Regulatory Overseas leverages this strength by preparing documentation that meets both Indian regulatory requirements (CDSCO, Schedule M) and international importing country standards simultaneously.
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