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LGM Pharma

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Nashville, Tennessee, US

About LGM Pharma

Type: Privately Held Size: 1-10 employees

LGM Pharma is an innovation-driven organization and a recognized global leader in sourcing, warehousing and distribution of quality CGMP APIs to leading pharmaceutical & biotech companies. LGM specializes in streamlining API supply chain management throughout R&D, clinical and... Show more »

LGM Pharma is an innovation-driven organization and a recognized global leader in sourcing, warehousing and distribution of quality CGMP APIs to leading pharmaceutical & biotech companies. LGM specializes in streamlining API supply chain management throughout R&D, clinical and commercial stages, ensuring technical competence and adherence to timelines & specifications for our clients while also providing expert guidance to navigate complex global regulatory submission strategies.

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Our Services (17)


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Compound Sourcing

Price on request
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Regulatory Affairs Consulting

Price on request

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

Price on request
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Powder Manufacturing

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Peptide Manufacturing

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Pharmaceutical 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 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

Price on request

Chemistry and Materials Services

Chemistry and Materials Services

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