Technical Services

Commercial Services

TECHNICAL SERVICES

Quality Assurance

QA advice - for pharmaceutical, veterinary and medical device manufacturers.

Batch Testing - wide range of chemical, physical and biological testing of products in internationally accredited laboratories.

Batch Release - Provision of Qualified Persons (QPs) for nomination on Licences, as required by Directives 2001/83/EC and 2001/82/EC as amended by 2004/27/ EC, for companies manufacturing in the UK or based in the UK and importing from countries outside the European Union.

Preparation of documentation systems - quality manuals, standard operating procedures, recall procedures, technical agreements for sub-contracted services etc.

Training - in-house courses in Good Pharmaceutical Manufacturing Practice for QA and Production staff & Good Distribution Practice for Warehouse staff.

Pre-inspection and supplier audits - to internal or external standards.

Active Pharmaceutical Ingredient (API) audits.

Assistance with ISO 9000 registration.

Production

Advice on contract manufacturer selection. Drawing up of Technical Agreements with contractors.

Regulatory & Medical Support

Medicines:-

Applications for Marketing Authorisations, Variations and Renewals, Wholesale Dealer's and Wholesale Dealer's (Import) Licences, Manufacturer's and Manufacturer's (Assembly Only) Licences.

Drug Master Files.

Expert Reports by recognised pharmaceutical, toxicological and medical experts

Negotiations with regulatory authorities.

Advice on Pharmacovigilance.

User Testing of Patient Information Leaflets  

Advice on Braille.

Medical Devices:-

Advice on classification under Directive 93/42/EEC.

Compilation of Technical Files for CE marking

COMMERCIAL SERVICES

Packaging advice - Patient Pack suitability & child resistance (according to current guidelines). Regulatory compliance of label and package text.

Medical writing - SmPCs, Labels and Patient Information Leaflets (in conformity with European regulations).

User Testing of Patient Information Leaflets  

Leaflets Advertising & Promotional Copy - advice on compliance with regulations and ABPI Code of Practice. Provision of expert pharmaceutical and medical signatories for approval of promotional copy.

Drug Tariff - Preparation and submission of data for product listing. Advice on interpretation of requirements.

Product Search & Acquisition - broad range of contacts, guaranteed confidentiality.

Product Divestments - seeking purchasers for pharmaceuticals and medical devices.

Product Evaluation - expert technical evaluation of novel products & inventions for potential investors in fields of pharmaceuticals, medical devices & medical equipment.

Marketing - Selection of appropriate UK and European partners and supplying technical support to them following their appointment.

Logistics Support - Assistance in selection of licensed Warehousing and Distribution partners for companies requiring ambient or cold storage and delivery for their products.

Provision of experienced "Responsible Persons" for nomination on Wholesale Dealer's Licences issued under Directive 2001/83/EC as amended by 2004/27/ EC.

Legal Advice - Recommendations to expert pharmaceutical lawyers.

Recruitment - Advertising, short-listing, selection.