Our Services

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.

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 methods are validated for use within Pharmadox laboratories through:

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.

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:

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:

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.