Callisto Consulting has a team with extensive professional experience. Working for pharmaceutical companies in a global environment. With the knowledge and experience of our staff we meet the exact requirements our clients expect in a highly regulated industry. The core team are skilled, dedicated professionals with a wealth of experience in:
- Preparation and submission of regulatory dossiers.
- Full technical support to manufacturers, including technical transfer, manufacturing support and analytical trouble-shooting.
- Complete Pharmacovigilance Services including QPPV appointment.
- Support with development projects.
- GMP, GLP and PV audits.
- G and P training.
- Readability testing of labels and leaflets.
We are passionate and committed in what we do and excel in working with our clients, using proven methods and techniques.
Through our group companies we can also provide extensive quality and technical services including:
- Pharmaceutical Manufacture including all major dosage forms.
- Quality Assurance.
- Quality Control.
- QP and RP services include batch release activities.
- Good Distribution Practice.
- Auditing both European and 3rd country sites.
Please see our “Partners” page for more details.
Callisto Regulatory Consulting can support you with Human, Veterinary and Herbal medicines in: Preparation of regulatory dossiers for the UK, Europe and other markets. Management of national, EU mutual ... [Read More]
Biocidal Products & Plant Protection Products
We can help you ensure that your biocidal products comply with the appropriate legislation: Support for applications under COPR and the Biocidal Products Regulation (BPR). Preparation of IUCLID dossiers. ... [Read More]
Callisto Consulting can support you in: Guidance on the appropriate legislation covering these products in different markets. Classification advice. Provide advice on data requirements and the regulatory activities required. ... [Read More]
Callisto Consulting can support you in: Setting up quality systems to fulfil Marketing Authorisation Holders Pharmacovigilance obligations. Weekly literature searching to identify potential adverse events related to Marketing Authorisation ... [Read More]
Readability Studies & Product Information
Callisto have established networks available to conduct readability testing of labels and leaflets and offer the following services: Readability review of labelling to comply with European requirements. Establishment of ... [Read More]
We bring hands on practical knowledge in a wide range of dosage forms including: Tablets. Powders. Liquids. Creams. Transdermal patches. Steriles. Investigational Medicinal Products. Herbal products. Advanced therapy medicinal ... [Read More]
QP & Responsible Person Services
QP certification of human and veterinary medicines including investigational medicinal products across a range of dose forms including tablets, capsules, powders, liquids, creams, steriles and metered dose inhalers. This service ... [Read More]