Global Experience and Expertise

We have submitted dossiers to various countries across regions like SEA, LATAM, Middle East, CIS, Africa, and Europe.

Latam

Ecuador
Chile
Bolivia
Venezuela
Costa Rica
Guatemala
Mexico

Sea

Myanmar
Cambodia
Laos
Indonesia
Vietnam
Sri Lanka
Malaysia

Africa

South Africa
Kenya
Tanzania
Uganda
Nigeria
Ghana
Cote d'Ivoire

Middle East

UAE
Oman
Iraq
Afghanistan
Iran

Europe

Algeria
Morocco
Egypt
France
Spain

CIS

Georgia
Uzbekistan
Turkmenistan

Our Services

Services including dossier compilation, preparation of QC documents, process validation reports, method development, BA-BE studies, and clinical services.

Dossier Compilation & Legal Advisory

Exposure of filling Dossier more than 75 plus Countries including Regulated /Semi regulated /ROW markets Dossier compilation as per regulatory /Country Guidelines Admin documents legalization /Apostille services Legal Support on Confidential Agreements for API & Finished Products Expertise in Query Handling for Regulated /Semi regulated /ROW markets Licensing & Admin Support Guidance Drug Master File (Open & Close part with GMP )

Quality Control

Expertise in Analytical Support in Quality Control documentation (Stability Data : Long Term , Accelerated (Protocol / Report) In-use stability Protocol /Report) Analytical Method Validation (HPLC/ UV Spectra/Titration and other Analytical methods ) Comparative Dissolution Profile

Microbiology

Expertise in Microbial Validation:
BET Validation
Sterility Validation
Media fill Validation
Microbial Assay Validation
Preservative Method Validation

Quality Assurance

Expertise in Quality Assurance documentation
Standard Operating Procedures
WHO Filling
Training programs
Site Master File
Process Validation Protocol / Report
Master Formula Record (MFR)
Batch Manufacturing Record (BMR)
COPP Application
Change Control / Deviation / CAPA / Product Recall / Market Complaints / Risk Management / Quality Manuals
Product License Application

Formulation & Development with tech Transfer

New Product Development data generation including Product Development Report (PDR) with full documentation support as per PICs/EU/ANVISA & WHO Standards Method Development Report (MDR) - Drug Excipient report & protocol, Comprehensive support for force degradation protocols and reports. Tech transfer Services

Clinical /Non – Clinical/ Pharmacovigilance Services

BA/BE studies
Biowaiver Reports
Toxicological Studies
Pharmacovigilance Study
Safety Update Reports
Risk Minimization Plan

Tenders

Export Tender Filling
Govt Tender Filling: Haffkine, Rmscl, Upmscl , Gmsd, Janaushadhi tenders

Audit Support

Plant upgradation & Assessment as per EU
ANVISA
MHRA & WHO-GMP Standard

Other Services

Training Programmes and Certification Courses
Basic Introduction to Regulatory Affairs
Advanced Basics of Regulatory Affairs
We customise our services as per our client’s requirements.

Custom Solutions for Your Unique Needs

At A Regpharm Consultancy, we understand that each client has unique challenges and objectives. That’s why we offer custom-tailored solutions designed to meet your specific regulatory needs. Our approach combines industry expertise, personalized consultation, and a deep understanding of your business to deliver the best results

Personalized Consultation
We work closely with you to understand the intricacies of your business and regulatory requirements.
Tailored Reporting and Documentation
Whether it’s dossiers, stability data, or validation reports, we customize documents to meet the specific needs of your markets.
Compliance Assistance
Our team helps you navigate local regulations with precision, ensuring seamless compliance with country-specific guidelines.
Advanced Solutions for Complex Challenges
From market entry strategies to overcoming regulatory hurdles, we provide strategic advice and hands-on support.

Why Choose A Regpharm Consultancy?

At A Regpharm Consultancy, we pride ourselves on being a trusted partner for regulatory compliance in the pharmaceutical industry. Here’s why we’re the preferred choice for our clients around the world.

10+

10+ Years of Expertise

Our extensive experience in the pharmaceutical market enables us to deliver top-notch solutions tailored to your needs.

Global Reach

We’ve successfully submitted dossiers across SEA, LATAM, Middle East, CIS, Africa, and Europe, ensuring compliance with diverse regulatory standards.

No-Error Dossiers

Our meticulous attention to detail ensures that all dossiers are error-free, saving time and preventing delays.

Compliance with International Standards

We work with EU-GMP, ANVISA, WHO-GMP, and more to ensure global regulatory compliance.

Customizable Services

We adapt our services to meet your specific requirements, providing flexibility and precision.

Skilled Team

Our team is equipped with the knowledge and tools needed to navigate complex regulatory landscapes.

Systematic Methodology

We follow a proven, structured approach to achieve the best outcomes for our clients.

Commitment to Quality

Quality is our top priority, ensuring every deliverable exceeds client expectations.

Our goal is to offer broad capabilities, competitive pricing, exceptional quality and outstanding service to each and every customer.

Quick Links

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Services

Preparation of Process Validation Report (PVR)Product Development Report (PDR)Master Formula Record (MFR)PSUR & RMP - Clinical Services

Contact Us

# 166, Kumauda Ward-6, PITHORGARH-262501 (Uttarakhand)

+91-9915913112

info@regpharmconsultancy.com

Welcome to RegPharm Consultancy

For any question or concern

Navigating Regulation, Ensuring Excellent Path

Yogita Upadhyay