Healthcare
Pharmaceuticals and medical devices are highly regulated with comprehensive requirements to ensure patient safety and product quality and efficacy.
Inter Scientific brings all the required skills together to offer our clients state-of-the-art knowledge to decrease the regulatory burden.
Healthcare Regulations
Our expertise span chemical, manufacture, control, non-clinical, clinical through to post-market commitments and pharmacovigilance. Led by European Qualified Persons, Inter Scientific is uniquely placed to help our clients reach their potential.
Compilation of pharmaceutical development data
Creation & Submission of Marketing Authorisation Application (MAA)
Post-market surveillance and commitments
HOW CAN WE ASSIST YOUR BUSINESS?
Whether you are manufacturing in-house or outsourcing, Inter Scientific can support you in ensuring appropriate practices and controls are in place for product compliance. Providing an independent audit enables the identification of areas of non-compliance and opportunities for improvement, either as part of a pre-inspection process or as part of continued internal audits.
We can assist in the design and development of quality management systems compliant with both EU GMP and ISO 13485, required to comply with both pharmaceutical and medical device regulations.
✓ Product shelf-life/stability studies
✓ Medical device verification and validation
✓ Product characterisation
✓ Microbial method suitability
✓ Cytotoxicity testing/biocompatibility
✓ Metals analysis
Let’s talk about your project
Benefit from working with an integrated science-based compliance & regulatory team so you don’t need to outsource to multiple companies – we keep our process smooth and simple.
To discover more about how we can support you to sell your healthcare products safely and legally, fill in the form or call to set up a meeting at
0333 344 2272.
