Regulatory Compliance

We provide end-to-end regulatory compliance services to help pharmaceutical, nutraceutical, herbal, and cosmetic companies navigate complex global regulatory environments and achieve successful product registrations.

Dossier Compilation

CTD (Common Technical Document):

Module 1: Regional & Administrative Information
Module 2: Quality Overall Summary
Module 3: Quality
Module 4: Non Clinical Study Reports
Module 5: Clinical Study Report

ACTD (ASEAN Common Technical Dossier):

Part I: Administrative Data
Part II: Quality
Part III: Non Clinical Study Reports
Part IV: Clinical Study Report

eCTD: Electronic Common Technical Document Publication

Country Specific Dossiers: Customized dossier formats for specific regulatory requirements

DMF Compilation (Open and Close Part)

Type I: Manufacturing Site, Facilities, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Materials Used in Their Preparation
Type III: Packaging Material
Type IV: Excipients, Colorants, and Flavors
Type V: FDA-accepted Reference Information

Bioequivalence Studies

We collaborate with highly recognized and reputable Contract Research Organizations (CROs) approved by local regulatory authorities (DCGI) and international regulatory bodies including US FDA, EMA, Health Canada, ANVISA, Iraqi Ministry of Health, and various National Medicines Regulatory Authorities (NMRAs) across African countries and other ministries of health.

Clinical / Non-Clinical Studies & Technology Transfer

We support clinical and non-clinical studies through collaboration with reputed, regulatory-approved CROs to ensure full compliance with DCGI, ICH-GCP, and GLP guidelines. Our services include Phase I–IV clinical trials and non-clinical safety studies.

We also provide comprehensive Product Technology Transfer and Plant Technology Transfer services, including seamless transfer of formulation know-how, manufacturing processes, analytical methods, validation protocols, and quality systems.

CDSCO Services

Sugam Account Opening
NSWS Portal Opening
Test Licenses (CT-10, CT-13, CT-16, CT-21)
Import License
Export NOC
Dual Use NOC
Medical Device Registration
Cosmetic Registration
Embassy Legalization & Apostille

FSSAI Services

FSSAI Registration
Product Approval
Plant Approval

Additional Services

RLD Procurement (US, EU, Brazil, and other countries)
Comparative Dissolution Profile
Analytical Method Validation
CEP Filing
Pharmacovigilance (PSUR, RMP, PSMF etc.)
Plant Setup & Greenfield Projects
Audit & Compliance (WHO-GMP, USFDA, EMA, PIC/S, EU-GMP, ANVISA, INVIMA, other Global MOHs)