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PHARMACEUTICAL

Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

 

Rely on our unique concept of service offerings on every complete product management where we assure you "SAVE COST ON EVERY STAGE" of the product development.

GENERIC PRODUCT & CLINICAL DEVELOPMENT

  • API Development and Sourcing 

 

  • Formulation Development

 

  • Dossier Development (CTD / eCTD)

 

  • Bioavailability / Bioequivalence studies in Healthy and Patient Population

 

  • Design, Conduct, Analysis and Interpretation of Clinical Studies

 

  • Pharmacokinetics & Biostatistics, IVIVC

 

  • Clinical Bioanalysis (Bioanalytical)

 

  • Quality Assurance (Clinical site Audits, Monitoring, etc.)

QUALITY ASSURANCE

  • cGMP Audits & Facility Assessment

 

  • Facility Qualification Audits in complaince with MHRA and USFDA regulations including 21 CFR.

 

  • Regulatory Compliance and Quality System Audit

 

  • Validation and Qualification

 

  • Training

 

  • Manufacturing Audits & Complaince Management

 

  • Laboratory Compliance (Compliance and Capacity assessments and Lab Set-up)

 

  • Quality System Preparation

SCIENTIFIC, MEDICAL  & REGULATORY

  • Assessment of scientific data and literature search

 

  • Medical Writing (Protocol, CRF, ICF, Clinical Study reports, etc.)

 

  • Module 2.4 and 2.5 (Clinical and Non-clinical overviews)

 

  • SmPC Comparison for EU

 

  • Product Leaflet and SmPC’s  & Investigational Brochure

 

  • Writing Regulatory Correspondence & Query Response

 

  • Submission via 505 (b) (2)

 

  • Dossier Compilation in eCTD

MEDICAL DEVICES

 

  • Concept Design & Development

  • Prototyping

  • Product Development

  • Pilot Manufacturing

  • Product & Process Validation

  • Clinical Study Management

  • IP Management

  • CE Marking

 

Our Medical Device arm is ISO 13485 certified.

 

Our Design and Development procedures omply with ISO 14971 standards and Risk Management.

INSTRUMENTAL & ANALYTICAL 

 

  • Permeability Studies

 

  • Analytical Method Development & Validation

 

  • Ion Chromatography

 

  • Extractable & Leachable Studies

 

  • In-Vitro Bioequivalence studies

 

  • Drug excipient compatibility studies

 

  • Dissolution studies

 

  • Stability testing

 

  • Impurity synthesis, Isolation and characterization

 

  • Residual solvent MD, MV & analysis

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