🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Ankleshwar
Empowering Ankleshwar’s Industry: US FDA | EU | WHO | PIC/S | CDSCO Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides dedicated Periodic Safety Update Report (PSUR) and PBRER services for the industrial leaders of Ankleshwar.
As a key hub for Active Pharmaceutical Ingredients (APIs) and Bulk Drugs, Ankleshwar-based firms face unique safety reporting challenges when supplying to regulated markets. Since 2008, we have been the scientific partner of choice, ensuring that your safety documentation is as high-quality as your manufacturing standards.
Who We Support in Ankleshwar
We provide specialized pharmacovigilance expertise to the core of Gujarat's industrial belt:
API & Bulk Drug Manufacturers: Providing safety data support for Drug Master Files (DMFs) and global supply chains.
Generic Drug Exporters: Navigating the complex safety reporting requirements of the US, EU, UK, and ASEAN regions.
SMEs in GIDC Ankleshwar: Transitioning from domestic production to high-growth international exports.
Quality & Regulatory Teams: Addressing health authority observations, "Warning Letters," or deficiencies related to safety monitoring.
Our PSUR Services
We offer specialized support that bridges the gap between bulk manufacturing and global regulatory acceptance:
PSUR/PBRER Preparation: High-quality, technical report writing following ICH E2C (R2) standards for global submissions.
Safety Data Gap Analysis: Evaluating your current pharmacovigilance data against international expectations (US FDA, EMA).
Authority Query Handling: Expert assistance in responding to technical questions from health authorities regarding your product's safety profile.
Benefit-Risk Evaluation: Conducting robust scientific assessments to prove the continued safety and efficacy of your products.
API Safety Summaries: Specialized safety documentation for active ingredients being supplied to global pharmaceutical innovators.
Global Experience & Trusted Expertise
750+ PSURs prepared and accepted by international regulators.
Since 2008: A long history of supporting Indian industry in reaching global markets.
Global Footprint: Extensive experience across Asia, Middle East, Africa, Europe, and North America.
Strong Regulatory Exposure: Proven success with US FDA, WHO, PIC/S, and CDSCO requirements.
Why Ankleshwar Companies Choose PSUR Central
"Turning manufacturing excellence into regulatory success."
API Focus: We understand the specific safety reporting nuances required for bulk drug manufacturers.
Non-Generic Approach: Our reports are scientifically written, providing in-depth signal detection rather than basic data entry.
Audit Readiness: We design reports to withstand rigorous inspections from the world's most demanding health authorities.
Confidentiality & Deadline Driven: We respect the fast-paced nature of the Ankleshwar industrial hub, delivering reports on time, every time.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The international standard for periodic safety reporting).
EU GVP Module VII (Periodic Safety Update Reports).
US FDA Post-Marketing Safety Reporting requirements (21 CFR 314.80).
CDSCO & PvPI requirements for the Indian market.
WHO and PIC/S aligned country regulations.
Get Started: Partner With Us
To initiate a customized project for your Ankleshwar-based facility, we typically require:
Product/API List and target global markets.
Approved Labeling/Specifications (SmPC / Product Monograph).
Sales & Patient Exposure Data for the reporting period.
Adverse Event Summaries (if applicable).
Submission Timelines.
Contact PSUR Central today to ensure your global exports remain compliant and authority-ready.
Global PSUR Compliance. Science-Driven. Authority-Ready.