Seamless Pharmacovigilance and Batch Release Solutions
At Indivirtus Healthcare Services Pvt. Ltd., our MAH and QP Support services provide comprehensive solutions for pharmaceutical manufacturers in the EU and UK. We offer MAH representation, QP batch certification, pharmacovigilance oversight, and regulatory alignment, ensuring GMP compliance and market readiness.
Our services include Marketing Authorization Holder (MAH) representation, Qualified Person (QP) batch certification, pharmacovigilance oversight, and local regulatory compliance for EU/UK markets, ensuring GMP and PV compliance.
MAH and QP services ensure regulatory compliance, seamless product release, and robust pharmacovigilance, supporting market access and patient safety in regulated markets.
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led MAH and QP solutions, providing compliant, efficient support for EU/UK market authorization and product release.
At Indivirtus Healthcare Services, our MAH and QP Support services are led by certified regulatory and pharmacovigilance experts with EU/UK compliance expertise. We provide MAH representation, QP batch certification, pharmacovigilance system management, and local regulatory alignment.
Our tailored approach ensures seamless compliance with EU GMP Annex 16, EU/UK MAH Guidelines, and EMA QP requirements, supporting both formal MAH setups and ad-hoc QP engagements for product release.
MAH Contract & Regulatory Interface Documentation: Formal agreements and regulatory support documents.
QP Declaration & Batch Release Reports: Certified documentation for product release.
Pharmacovigilance (PV) System Management Plan: Comprehensive PV oversight strategy.
Local Representative Letters & Compliance Proof: Documentation for EU/UK regulatory alignment.
Our MAH and QP Support services align with stringent EU and UK standards, ensuring your operations are audit-ready and compliant with regulated markets. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence and market access.
Our MAH and QP Support services are essential for pharmaceutical manufacturers requiring EU/UK market compliance. Ideal for MAH representation, batch release, and pharmacovigilance oversight, our solutions support regulatory compliance. Key use cases include establishing MAH setups for new products, facilitating QP batch certifications, and ensuring PV compliance in the EU/UK.
Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led MAH and QP solutions backed by certified regulatory and pharmacovigilance professionals with EU/UK experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, efficient solutions, driving regulatory success and market readiness.
A MAH is legally responsible for the product in the EU/UK market, including regulatory compliance, pharmacovigilance, and quality oversight.
A Qualified Person (QP) certifies that each batch has been manufactured and tested in accordance with GMP and marketing authorization conditions before release.
Yes, if you are a non-EU company, a local representative is required to interface with EU regulatory authorities and fulfill post-marketing obligations.
Absolutely. We offer QPPV services, PSMF management, and continuous PV oversight to ensure compliance with EMA and national authority requirements.
Pricing depends on engagement type—per batch, annual MAH retainer, or full-service PV and compliance support. Contact us for tailored quotes.
Our services include MAH representation, QP batch certification, pharmacovigilance system management, and local regulatory alignment for EU/UK compliance.
Pharmaceutical manufacturers requiring EU/UK MAH representation, QP batch release, or PV oversight benefit from our tailored solutions.
Our services align with EU GMP Annex 16, EU/UK MAH Guidelines, EMA QP Requirements, and WHO GMP standards, ensuring compliance.
Clients receive MAH contracts, QP declarations, PV system plans, and local representative compliance documents.
Yes, our services are tailored to your specific product, regulatory, and PV requirements, ensuring compliant solutions.
We provide QP certifications for batch release and comprehensive PV system management to ensure compliance and market readiness.