• Pharmaceutical Development & QC Testing

• Formulation Development

• Biopharmaceutical Characterization

• Analysis of Impurities & Contaminants

• Protein & Peptide Identification

• In Vitro Toxicology Testing

• Specialty Product Analysis

• Biosafety Testing of Biologics, Antibodies, Gene &

• Cell Therapies

• Stability Prediction

• Extractables & Leachables Testing

• Package & Container Testing

• Clinical supplies manufacturing

• Clinical supplies packaging

• Scale-up

• Technical or Site Transfers

• Launch product(s) for commerce

PRODUCTS in VIALS, PFS & CARTRIDGES

• Biologics: Antibodies, Antibody Drug Conjugate, Cell and Gene Therapies

• Innovative Drug Delivery Platforms: Injectables and Ophthalmic

• Small Molecules: Potent Compounds

• Specialized drug delivery technologies

AUTOMATED INJECTABLE FILLING LINE

• Glass vial filling equipment train (single use equipment, filling & stoppering, SIP/CIP, capping/ crimping, isolator) (model and specs. to be disclosed)

• Pre-filled Syringes, Cartridges & Vials: Multi-purpose filling line (tray technology)

• Freeze dryer for biologics and other pharmaceutical drug products (model and specs. to be disclosed)

• Change parts will be customized as per client product(s) requirements

• New product R&D for pre-clinical studies

• R&D for proof of concept studies

• Formulation development and optimization

• Market dosage form selection, manufacturing process and packaging configuration

• Troubleshoot existing formulation, manufacturing process and packaging configuration

• Analytical method development and / or troubleshoot analytical methods for API, intermediate and finished product

• Pharmaceutical equivalence

• Bioavailability and clinical equivalence

• Product due diligence

• Trouble-shoot existing product

• FDA filings for:

  • Pre-IND (Pre-Investigational New Drug)

  • IND (Investigational New Drug)

  • NDA (New Drug Application)

  • BLA (Biologics License Application)

  • ANDA (Abbreviated New Drug Application)

  • FDA comment letters

• Site cGMP (Current Good Manufacturing Practices)

• Regulatory Compliance

• Post-Marketed Product(s)

• Audit, assess and prepare a manufacturing, packaging and analytical testing laboratory for FDA inspections

• Audit, assess and prepare for pre-approval inspections for NDA (brand), BLA (biologics brand or biosimilar) and ANDA (generic) products

• Remediation activities to meet cGMP requirements

• Support FDA-483 and / or warning letter response

• Consent decree remediation plans

• On-site assistance during FDA inspections

• Project management for all remediation programs

• Failed PAI Inspections

• Coordinating recall efforts

• Import detention resolution

• Audit, assess and prepare for pre-approval inspections for NDA (brand), BLA (biologics brand or biosimilar) and ANDA (generic) products

• Inspect facilities, equipment, and laboratories

• Review pertinent documents that support GMP and client specifications

• Assess quality management systems, SOPs and associated cGMP documents

• Review validation of manufacturing equipment, product process, and equipment cleaning

• Assess vendor certification programs

• Review method validation (analytical and microbiological)

• Evaluate data integrity

• Computer systems validation (CSV) audits

• 21 CFR part 11 compliance review

• Trial Master File audits

• Vendor audits including contract research organizations (CROs), Central Labs, IRBs, and Data Management.

• Review and audit of dossier for a product

• Purpose: acquisition by a company or file with FDA or get FDA approval by addressing FDA comment letters

• Pre-clinical, IND, Phase 1, 2 or 3 clinical studies data and respective chemistry, manufacturing and controls (CMC) report, product development report and ANDA

• Analytical & QC data review and audit for FDA submission / exhibit batch

• Process validation assessment and remediation to meet US-FDA requirements

• Technology transfer to a US-FDA approved manufacturing and testing site

• Scale-up to commercial batch size of a product

• Review preliminary construction design documentation/ engineering drawings to assure compliance

• Develop preliminary hazard analysis

• Assess and review requirements, specifications, and drawings for water systems, HVAC, sterilization, temperature and humidity controls

• Develop laboratory, environmental and processing-room requirements

• Qualify facilities for sterile, non-sterile products

• Project management of materials, equipment and personnel

• Perform equipment IQ/ OQ/ PQ

• Develop facility validation and qualification protocols and execution

• Conduct regular audits during pre, present and post construction and installation phases

• Quality system development

• CAPA management

• Gap analysis

• Readiness assessment

• SOP development

• Technical writing: SOP’s, validation protocols & reports, annual product reviews, audit responses, and other technical reports

• Electronic quality management systems

• Process validation

• Cleaning validation

• Equipment qualification and validation

• Laboratory controls

• Analytical method validation

• Develop training programs

• Scientific and technical expert advisory for intellectual property / patent of a product during a patent litigation

• Bioanalytical Testing

• Physiochemical Characterization

• Technology Transfer

• Endotoxin

• Bioburden

• Sterility

• Microbiological tests & assay

• Bioanalytical / Analytical Testing

• Physiochemical Characterization

• Pharmaceutical Formulation

• Process Development & Validation