Our Services

Laboratory service

Quality Control - Chemistry

Pharmadox Laboratories are set up to enable the separate, safe and contained handling of hazardous as well as non-hazardous products. Site handling of hazardous products is achieved through the design of separate but interlinked laboratories, both having an extensive range of equipment for analytical and physical chemistry analysis.

This selection of equipment enables a vast range of analytical testing capabilities whilst ensuring capacity and quality requirements. Moreover our seperate Microbiology laboratory allows us to perform Microbiology testing on both Sterile as wel as non sterile moliqules.

Our range of equipment and techniques enable us to handle various dosage forms.

Laboratory service

Quality Control - Microbiology

Our separate Microbiology laboratory allows us to perform Microbiological testing on both sterile as well as non-sterile molecules. Our range of equipment and techniques enable us to handle various dosage forms.

  • QMS creation
  • Compliance issues and problem solving
  • Analytical Method development & optimisation
  • Geometrical Method transfers
  • Cleaning and Process Validation Strategies
  • Good Laboratory Practices
  • Dossier Due Diligence evaluations
  • Dossier upgrading
  • Preparation of Module 1
  • Preparation of product information (text, user testing, translation)
  • Stability Study Design
  • Pharmacovigilance

Product development

Pharmadox Healthcare Ltd is an Investigational Medicinal Product (IMP) licensed site enabling close collaboration with product development companies in the generic and proprietary pharmaceutical Industry in a myriad of aspects from product conception through dossier compilation, product registration and ultimately to product QP release and Distribution in the EU through the provision of the below services:

  1. Product Formulation Development
  2. Analytical Method Development
  3. Analytical Method Validation
  4. Regulatory support during product development
    • Regulatory input to ensure approvability.
    • Specification setting – for drug substances, drug products, excipients, packaging materials.
  5. Stability Study Design
    • Assistance in designing various types of studies – ICH, bulk, photostability, reconstitution and dilution, in-use and dose dispensing, compatibility. In addition to setting up cost-effective global stability protocols, involving reduced designs and multiple climatic zones.
    • Compilation of essential similarity and biowaiver arguments.
  6. Dossier assembly
    • Compilation of Module 3, including critical evaluation of documentation to ensure rapid approval.
    • Preparation and signing of quality overall summary (QOS).
  7. Audit
    • Dossier (including DMF) audit, gap analysis and risk assessment.
    • Dossier upgrading.
  8. Submission
    • Regulatory applications and procedures.
    • Assistance in responding to CMC deficiency letters.
    • Help in providing clear, complete responses to keep procedures as short as possible.
    • Variations – classification, compilation and expert comments.

Analytical method validation

Analytical methods are validated for use within Pharmadox laboratories through:

  • Analytical Method Transfer by comparative analysis
  • Reduced Analyticaal Method validation
  • Full Analytical Method re-validation
  • Geometrical Analytical Transfers

Analytical research and development

Our proficient and experienced team of chemists can develop new analytical methodology as well as optimize current methodologies in order to increase throughput and efficiency as well as ascertain the critical attributes of the methods followed by their respective analytical validation in line with Ph. Eur. and ICH guidelines.

EU QP releases, Quality Assurance & Regulatory Affairs

With a number of QPs complying to Directive 2001/83/EC on our licence in addition to a supporting team of technical personnel, each with several years of experience in various sectors of the industry, Pharmadox is well geared to address all your Quality and regulatory requirements in various sectors encompassing multiple dosage forms from tablets and capsules to sterile liquids.

Our services in this field include:

  • Third party E.U. and non E.U. cGMP site audits by our experienced team of auditors, full GAP analysis for companies preparing for first time EU authority audit.
  • Providing API declaration for the submission of New Product Application to European Regulatory Authorities.
  • EU Batch Certification and QP Batch release.
  • Planning of Supply chain logistics which will also include data flow, invoicing route and product flow from a non-EU manufacturer to the EU-wholesaler.
  • Our team of highly experienced QPs and QA personnel can offer a wide range of consultancy services:
    • QMS creation, optimisation and validation of systems
    • Regulatory support and filing of applications
    • Creation and implementation of Quality System
    • Compliance issues
    • Auditing and GAP report
    • CAPA

Secondary packaging, re-packaging & over-labelling

Our team of highly dedicated and experienced personnel can help you find a tailored solution for your product requirements. We are capable of handling high volumes on simultaneous lines whilst ensuring a good quality product in EU cGMP conditions.

Flexible and validated operational mechanisms, several years of experience, and highly trained personnel guarantee an optimised turnaround time for our clients. We continuously work against very tight deadlines and pride ourselves in successfully meeting all our client’s deadlines.

Services in this field include:

  • Breaking of Bulk and reconfiguration of Packaging
  • Replacement of outer carton and/or PIL
  • Visual Inspection work
  • Over-Labelling

Warehouse and supply chain

Through close cooperation with leading service providers we strive to further extend our range of services in a one stop concept in terms of air, sea and road logistics for the convenience of our clients.

  • Importation and Customs clearance of bulk or finished products and APIs.
  • Stock Piling and Warehousing; We are well equipped to store your product at our facility. With over 2000m2 of combined warehousing space, all to pharma specifications we can handle both large and small consignments with equal efficiency.
  • Our houses can cater for storage conditions between 15 to 25°C and also cold chain storage of 2-8°C.
  • Breaking of Bulk and Pack to Order for country specific packaging, with bespoke solutions to satisfy market demands.
  • Managing Day-One Launches according to the planned launch sequence based on patent expiry, using our in-house logistics team along with tried and proven service providers with several years of experience in this sector.
  • Time critical transportation of the released batches from Malta to the EU-customers, with Thermo-controlled vehicles  (heated/cooled), supported by an online tracking system.
  • Local customs clearance service within a few hours.