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LGM Pharma

Nashville, Tennessee, US

LGM Pharma is an expert active pharmaceutical ingredients (APIs) distribution & sales company involved in imports and supply of a wide range of quality, bulk Pharmaceutical & Nutraceutical Products for the compounding and R&D industries.

We specialize in supplying our customers with a wide range of APIs supported by integrated technical capabilities and access to complete regulatory DMF documentation, suitable for various R&D stages through commercial formulation production.

Our products originate from our API manufacturing partner sites who are approved by the leading health authorities, such as the US-FDA, EDQM, TGA, UK-MHRA etc. Some of the APIs that we supply are manufactured via non-infringing processes which would be suitable for Paragraph IV challenges / early launches in regulated markets.

Through competent assistance by our sales department, complete technical & regulatory... Show more »

LGM Pharma is an expert active pharmaceutical ingredients (APIs) distribution & sales company involved in imports and supply of a wide range of quality, bulk Pharmaceutical & Nutraceutical Products for the compounding and R&D industries.

We specialize in supplying our customers with a wide range of APIs supported by integrated technical capabilities and access to complete regulatory DMF documentation, suitable for various R&D stages through commercial formulation production.

Our products originate from our API manufacturing partner sites who are approved by the leading health authorities, such as the US-FDA, EDQM, TGA, UK-MHRA etc. Some of the APIs that we supply are manufactured via non-infringing processes which would be suitable for Paragraph IV challenges / early launches in regulated markets.

Through competent assistance by our sales department, complete technical & regulatory capabilities and fast delivery of high quality ingredients at competitive prices, LGM has become a preferred API supply source.

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LGM Pharma has not listed any services.

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Compound Sourcing
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Regulatory Affairs Consulting
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Within the framework of an API project, LGM Pharma can provide comprehensive regulatory services,
including:

  • Elaboration and evaluation of Active Substance and US-Drug Master Files (ASMF & DMF),
  • Quality Overall Summary (QOS) and Certificates of Suitability (CEP)
  • Escort of registration procedures (MRP, DCP)
    -... Show more »

Within the framework of an API project, LGM Pharma can provide comprehensive regulatory services,
including:

  • Elaboration and evaluation of Active Substance and US-Drug Master Files (ASMF & DMF),
  • Quality Overall Summary (QOS) and Certificates of Suitability (CEP)
  • Escort of registration procedures (MRP, DCP)
  • Independent GMP audit reports
  • Regulatory strategy development and implementation
  • Regulatory submission oversight, management, preparation, maintenance, and quality assurance
  • Regulatory authority interactions, including serving as US Agent
  • Regulatory compliance gap analysis and issue resolution
  • Scientific, regulatory, and due diligence reviews of regulatory documents and submissions
  • Regulatory and scientific document development, preparation, and quality assurance
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Protein Manufacturing
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Powder Manufacturing
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Peptide Manufacturing
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Drug Manufacturing
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Compound Manufacturing
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Custom Manufacturing
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Excipients
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Scientific Sourcing
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Regulatory Affairs Services
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Drug Discovery & Development
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Project and Process Management
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Manufacturing Services
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Process Consulting
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Formulation Services
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Compound Sourcing and Management
Price on request

Compound Sourcing and Management Services

Compound Sourcing and Management Services

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Chemistry and Materials
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Chemistry and Materials Services

Chemistry and Materials Services

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