Pharma Experts

Pharma Experts

India’s Trusted Pharma Documentation Experts

CTD | eCTD | AMV | RMP | PSUR | GMP Compliance

Our Services

CTD / eCTD Documentation

Complete Module 1–5 dossier preparation as per EU/US guidelines.

AMV (Analytical Method Validation)

Preparation of validation protocols and reports as per ICH guidelines.

Deficiency Response

Professional response writing for EU/US regulatory queries.

Stability Reports

ICH-compliant stability study reports and data evaluation.

Process Validation

Preparation of process validation protocols and reports.

SOP Documentation

Standard Operating Procedures as per GMP compliance.

Contact Us

Email: sbmpharmaalldoc@gmail.com

Phone: +91 8800196897 | WhatsApp Chat

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Our Expertise

(With over 13 years of experience in pharmaceutical regulatory documentation, I provide reliable and efficient support to pharmaceutical companies and consultants across global markets. My expertise lies in preparing high-quality regulatory documents in compliance with international guidelines, including CTD/eCTD submissions, AMV documentation, deficiency responses, stability reports, and GMP-compliant documentation. Throughout my career, I have successfully contributed to the registration of more than 1200 pharmaceutical products across multiple international markets, including the Philippines, Cambodia, Myanmar, and Vietnam. This extensive exposure has given me a deep understanding of country-specific regulatory requirements and submission processes, enabling me to deliver accurate and compliant documentation tailored to each market. I am committed to delivering fast, precise, and cost-effective solutions without compromising on quality. My strong background in both Quality Control and Regulatory Affairs allows me to ensure that all documentation meets the highest standards expected by regulatory authorities. Whether you are a pharmaceutical company, exporter, or consultant, I can support your documentation needs with professionalism, confidentiality, and efficiency. My goal is to simplify the regulatory process for my clients and help them achieve faster approvals in global markets. I am open to freelance and remote collaborations and always focused on building long-term professional relationships based on trust, quality, and timely delivery. )