Our Services

Comprehensive Pharmaceutical and Preventive Healthcare Solutions for Global Markets

What We Offer

End-to-end pharmaceutical solutions spanning sourcing, development, manufacturing, and regulatory compliance.

Indenting & Direct Global Sourcing

Our Structured Sourcing Model

01

Source Identification

Verification of manufacturing credibility, scale & technical capability.

02

cGMP Review

Assessment of compliance status, product licensing & certifications.

03

Direct Transparency

Client-manufacturer direct technical interaction for clarity & accountability.

04

Risk Mitigation

Long-term supply relationships over opportunistic pricing; continuity focus.

05

Documentation Support

Regulatory documentation aligned to WHO-GMP / US FDA standards.

Our Differentiators

  • On-site source verification & evaluation
  • Direct manufacturer transparency
  • Structured documentation for regulated markets
  • Quality assurance with replacement policies
  • Active shipment monitoring to buyer's port
  • Long-term supplier continuity focus
"At Longevion Pharma, sourcing is not transactional — it is systematic."

CRO / CDMO — API & Intermediates

5
PhD Scientists
30+
Research Staff
25+
Years Leadership
cGMP
Pilot Plant

Research & Development

Route scouting, process development, NCE synthesis, peptide synthesis.

Analytical Development

Method development & validation, salt & polymorph screening, impurity characterization.

Project Models

FTE projects, milestone-based programs, gram to multi-kilo custom synthesis.

Pilot & cGMP

cGMP-aligned pilot plant, clinical trial materials, analytical validation support.

Hyderabad-based R&D Facility with International Post-Doctoral Exposure

Contract Manufacturing

Strategic co-investment in a USFDA-compliant API manufacturing facility in India.

cGMP-Aligned Production

Manufacturing processes fully aligned with cGMP standards and international regulatory expectations.

Regulated Market Documentation

Complete documentation packages to support US FDA, WHO-GMP and other regulated market filings.

Manufacturing Transparency

Direct oversight and transparency throughout the production process for full accountability.

Long-Term Supply Security

Strategic investment model ensuring continuity and stability for API supply commitments.

Development to Commercialization

Seamless transition from lab-scale development through pilot to commercial manufacturing.

Qualified Partner Network

Collaboration with audited manufacturing partners for complex chemistry and niche APIs.

Formulations CRO

Integrated formulation development and technology transfer for Finished Dosage Forms (FDF).

Development Capabilities

  • Pre-formulation studies & prototype development
  • Dissolution method development & compatibility studies
  • Stability studies & manufacturing process optimization
  • Solid oral dosage forms and other formulations

Technology Transfer & ANDA Services

  • Demonstration & exhibit batch execution
  • Process validation support & on-site coordination
  • Outright sale of ANDA dossiers with full documentation
  • RLD procurement for bioequivalence studies

Formulation Tech Package

  • Literature review & product strategy
  • Quality Overall Summary (QOS)
  • Drug substance & product specifications
  • Manufacturing process & batch formula
  • Critical process parameter controls
  • Analytical testing procedures
  • Stability data & packaging specifications
  • Bioequivalence summaries (where applicable)

RLD — Reference Listed Drug Sourcing

Our RLD Sourcing Services

  • Identification of correct RLD per USFDA Orange Book
  • Procurement from authorized distribution channels
  • Verification of batch details and labelling
  • Controlled storage and handling throughout
  • Shipment coordination with complete documentation
  • Batch traceability and supply confirmation

Why RLD Integrity Matters

  • Bioequivalence study outcomes
  • Regulatory submission accuracy
  • ANDA filing timelines
  • Product development alignment

Authentic sourcing. Traceable supply. Minimized regulatory risk.

Analytical R&D Capabilities

Comprehensive analytical research and development for APIs, intermediates, and NCEs aligned with international regulatory standards.

Method Development & Validation

  • RP, NP & chiral HPLC method development
  • HPLC with PDA, RI, CAD & ELSD detectors
  • GC & Headspace GC (OVI analysis)
  • Analytical method transfer to QC units
  • Preparation of analytical tech packs

Impurity Profiling & Characterization

  • Comprehensive impurity profiling
  • Structure elucidation using LC-MS & GC-MS
  • Impurity isolation & characterization
  • Stability-indicating method development

Solid-State & Advanced Studies

  • Salt screening & polymorph identification
  • Compatibility studies with formulation team
  • Preparative HPLC (achiral & chiral)
  • Isolation of reference standards

Quality & Compliance Focus

  • Instrument calibration per scheduled protocols
  • Documentation alignment for regulatory filings
  • Method robustness and reproducibility
  • Support for development and cGMP environments

Need a Pharmaceutical Solutions Partner?

Get in touch to discuss your sourcing, development, or manufacturing requirements.

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