No MA? No Problem. We Bring Your Product to Market.
We match high-potential products with existing MAs in regulated markets. You focus on manufacturing—we handle the rest, from tech transfer to expansion.
Rapid deployment of your portfolio using existing regulatory authorizations (MA) in Europe or other regulated markets.
Rapid deployment of your portfolio using existing regulatory authorizations (MA) in Europe or other regulated markets.
Rapid deployment of your portfolio using existing regulatory authorizations (MA) in Europe or other regulated markets.
Portfolio Acceleration
Portfolio Acceleration
Portfolio Acceleration
Regulatory-Ready Launch
Regulatory-Ready Launch
Regulatory-Ready Launch
Market Expansion
Market Expansion
Market Expansion
Key Performance
Key Performance
Key Performance
Meditra provides hands-on expertise in converting technical documentation into ICH-compliant formats (eCTD, CTD modules, GMP QMS integration), ensuring that your product is registration-ready in any regulated zone.
We connect manufacturers with vetted marketing authorization (MA) holders to accelerate product entry without the burden of full registration
We connect manufacturers with vetted marketing authorization (MA) holders to accelerate product entry without the burden of full registration
We connect manufacturers with vetted marketing authorization (MA) holders to accelerate product entry without the burden of full registration
Our bilingual teams in China and Europe ensure fluent communication and cultural alignment during tech transfer, negotiation, and audits.
Our bilingual teams in China and Europe ensure fluent communication and cultural alignment during tech transfer, negotiation, and audits.
Our bilingual teams in China and Europe ensure fluent communication and cultural alignment during tech transfer, negotiation, and audits.
We identify and secure licensing, co-marketing, and business development partners to turn validated production into real commercial deals
We identify and secure licensing, co-marketing, and business development partners to turn validated production into real commercial deals
We identify and secure licensing, co-marketing, and business development partners to turn validated production into real commercial deals
Our Process
Our Process
Our Process
01
Portfolio Viability Check
We conduct a rigorous evaluation of the manufacturer’s product dossier, GMP status, and facility readiness, benchmarking them against EMA, WHO, and ICH requirements. This phase confirms whether the asset is eligible for international market adaptation through existing or transferable authorizations. We review CMC documentation, existing variations, stability data, and process validations to mitigate compliance risks before engaging in regulatory or commercial commitments.
01
Portfolio Viability Check
We conduct a rigorous evaluation of the manufacturer’s product dossier, GMP status, and facility readiness, benchmarking them against EMA, WHO, and ICH requirements. This phase confirms whether the asset is eligible for international market adaptation through existing or transferable authorizations. We review CMC documentation, existing variations, stability data, and process validations to mitigate compliance risks before engaging in regulatory or commercial commitments.
01
Portfolio Viability Check
We conduct a rigorous evaluation of the manufacturer’s product dossier, GMP status, and facility readiness, benchmarking them against EMA, WHO, and ICH requirements. This phase confirms whether the asset is eligible for international market adaptation through existing or transferable authorizations. We review CMC documentation, existing variations, stability data, and process validations to mitigate compliance risks before engaging in regulatory or commercial commitments.
02
MA Alignment Strategy
We identify compatible Marketing Authorization (MA) holders and design a regulatory framework that aligns technical ownership, pharmacovigilance duties, and commercial control. This includes defining roles in PSUR submissions, quality oversight, and batch release procedures. Our team ensures that both parties—manufacturer and MA holder—comply with shared responsibilities under EU or regional guidelines, while maintaining clear accountability across the lifecycle of the product.
02
MA Alignment Strategy
We identify compatible Marketing Authorization (MA) holders and design a regulatory framework that aligns technical ownership, pharmacovigilance duties, and commercial control. This includes defining roles in PSUR submissions, quality oversight, and batch release procedures. Our team ensures that both parties—manufacturer and MA holder—comply with shared responsibilities under EU or regional guidelines, while maintaining clear accountability across the lifecycle of the product.
02
MA Alignment Strategy
We identify compatible Marketing Authorization (MA) holders and design a regulatory framework that aligns technical ownership, pharmacovigilance duties, and commercial control. This includes defining roles in PSUR submissions, quality oversight, and batch release procedures. Our team ensures that both parties—manufacturer and MA holder—comply with shared responsibilities under EU or regional guidelines, while maintaining clear accountability across the lifecycle of the product.
03
Tech Transfer Prep
We structure and oversee the full tech transfer process: from data bridging to validation batch execution and QA/QC alignment. We assess site comparability and provide gap analysis between original and destination facilities. Meditra coordinates the execution of engineering batches, supports method transfer, and ensures that analytical procedures meet target authority expectations. This includes stability protocols, process validation, and clean documentation trails for audit-readiness.
03
Tech Transfer Prep
We structure and oversee the full tech transfer process: from data bridging to validation batch execution and QA/QC alignment. We assess site comparability and provide gap analysis between original and destination facilities. Meditra coordinates the execution of engineering batches, supports method transfer, and ensures that analytical procedures meet target authority expectations. This includes stability protocols, process validation, and clean documentation trails for audit-readiness.
03
Tech Transfer Prep
We structure and oversee the full tech transfer process: from data bridging to validation batch execution and QA/QC alignment. We assess site comparability and provide gap analysis between original and destination facilities. Meditra coordinates the execution of engineering batches, supports method transfer, and ensures that analytical procedures meet target authority expectations. This includes stability protocols, process validation, and clean documentation trails for audit-readiness.
04
Packaging Localization
We manage all aspects of packaging adaptation, including language translations, leaflet compliance, serialization, tamper-proofing, and GS1 barcoding for EU FMD. We also adapt designs for regional visual norms, coordinate supplier readiness, and ensure packaging component approvals are in place. This process is critical for timely release and market access, minimizing delays due to regulatory non-conformities or artwork inconsistencies with health authority requirements.
04
Packaging Localization
We manage all aspects of packaging adaptation, including language translations, leaflet compliance, serialization, tamper-proofing, and GS1 barcoding for EU FMD. We also adapt designs for regional visual norms, coordinate supplier readiness, and ensure packaging component approvals are in place. This process is critical for timely release and market access, minimizing delays due to regulatory non-conformities or artwork inconsistencies with health authority requirements.
04
Packaging Localization
We manage all aspects of packaging adaptation, including language translations, leaflet compliance, serialization, tamper-proofing, and GS1 barcoding for EU FMD. We also adapt designs for regional visual norms, coordinate supplier readiness, and ensure packaging component approvals are in place. This process is critical for timely release and market access, minimizing delays due to regulatory non-conformities or artwork inconsistencies with health authority requirements.
05
Commercial Launch Setup
We lead the final phase with commercial planning, defining pricing strategy, branding (private label or co-brand), route-to-market, and initial batch roll-out. This includes logistics setup, distribution partner onboarding, and alignment with local commercial regulations. We provide continued regulatory support post-launch (renewals, variations), manage forecasting with buyers, and create mechanisms for lifecycle management to sustain and grow the product footprint globally.
05
Commercial Launch Setup
We lead the final phase with commercial planning, defining pricing strategy, branding (private label or co-brand), route-to-market, and initial batch roll-out. This includes logistics setup, distribution partner onboarding, and alignment with local commercial regulations. We provide continued regulatory support post-launch (renewals, variations), manage forecasting with buyers, and create mechanisms for lifecycle management to sustain and grow the product footprint globally.
05
Commercial Launch Setup
We lead the final phase with commercial planning, defining pricing strategy, branding (private label or co-brand), route-to-market, and initial batch roll-out. This includes logistics setup, distribution partner onboarding, and alignment with local commercial regulations. We provide continued regulatory support post-launch (renewals, variations), manage forecasting with buyers, and create mechanisms for lifecycle management to sustain and grow the product footprint globally.
Experience matters
Experience matters
Experience matters
“Working with Meditra accelerated our expansion beyond expectations. Their hands-on support in both licensing and tech transfer made them an essential partner.”
Carlos A. Heinemann
Global Market Access Director, Novintis Biocare
“Working with Meditra accelerated our expansion beyond expectations. Their hands-on support in both licensing and tech transfer made them an essential partner.”
Carlos A. Heinemann
Global Market Access Director, Novintis Biocare
“Working with Meditra accelerated our expansion beyond expectations. Their hands-on support in both licensing and tech transfer made them an essential partner.”
Carlos A. Heinemann
Global Market Access Director, Novintis Biocare
Solving the China-to-World Bottleneck With Expert Regulatory Conversion and Strategic Representation
Solving the China-to-World Bottleneck With Expert Regulatory Conversion and Strategic Representation
Solving the China-to-World Bottleneck With Expert Regulatory Conversion and Strategic Representation
Chinese manufacturers often face hurdles during tech transfer due to differing regulatory standards, documentation expectations, and quality benchmarks in global markets. Meditra bridges these gaps with localized regulatory expertise, ensuring smooth adaptation of technical processes, packaging, and analytical methods in full compliance with ICH and GMP standards.
Documentation Gaps: We adapt SOPs, CoAs, and protocols into ICH/EMA-compliant formats.
Documentation Gaps: We adapt SOPs, CoAs, and protocols into ICH/EMA-compliant formats.
Documentation Gaps: We adapt SOPs, CoAs, and protocols into ICH/EMA-compliant formats.
Validation Alignment: We coordinate EU-accepted process validation and analytical method transfer.
Validation Alignment: We coordinate EU-accepted process validation and analytical method transfer.
Validation Alignment: We coordinate EU-accepted process validation and analytical method transfer.
Stability Requirements: We define and manage stability protocols per regional shelf-life expectations.
Stability Requirements: We define and manage stability protocols per regional shelf-life expectations.
Stability Requirements: We define and manage stability protocols per regional shelf-life expectations.
Packaging Compliance: We localize artwork and secondary packaging to meet target-market norms.
Packaging Compliance: We localize artwork and secondary packaging to meet target-market norms.
Packaging Compliance: We localize artwork and secondary packaging to meet target-market norms.
Audit Readiness: We conduct mock GMP inspections and help prepare for EU QP audits.
Audit Readiness: We conduct mock GMP inspections and help prepare for EU QP audits.
Audit Readiness: We conduct mock GMP inspections and help prepare for EU QP audits.
