HPS supplies specials in accordance with bona fide unsolicited orders from doctors or pharmacists who have demonstrated a case of special clinical need which cannot be met by a licensed product.

We manufacture a range of sterile and non-sterile specials. Sterile medicines may be terminally sterilised by autoclaving or dry heat, or may be sterilised by filtration and filled under aseptic conditions (e.g. in a hydrogen peroxide sterilised isolator).

Our non-sterile products include creams and ointments, liquid oral preparations and external liquids. In addition a large range of products are prepared for individual patients and manufactured within 24-48 hours of receipt of request. All products are manufactured under a comprehensive quality management system and are released after appropriate quality control procedures.

Allied to the above, HPS also offers clients large scale over-labelling and re-packing of medicines covering all dosage forms.

All contract manufacturing is performed to cGMP and carried out at our state-of-the art MHRA approved manufacturing facilities based in the UK. All activities are supported by internal quality control and our quality management systems which meet the requirement and expectations of regulatory agencies and customers; we welcome all clients to audit our procedures. Governance is ensured and captured through mutually agreed confidentiality, supply, quality and technical agreements specific to each contract manufacturing project. Further, and if so required by clients, HPS can draw upon its experience of managing technology transfer to client determined third parties, which therefore provides clients with added strategic flexibility.

Our range of contract manufacturing services at a glance:

Sterile pharmaceuticals:

• Infusions
• Prefilled syringes
• Injections
• Ampoules
• Vials
• Eye-drops

Non-sterile pharmaceuticals

• Capsules
• Oral solutions and suspensions
• Externally applied liquids
• Creams
• Ointments
• Powders
• Suppositories
• Pastes

Over-labelling of medicines

Re-packing of medicines

Our new product development team consisting of formulation, pharmaceutical and analytical development scientists have a proven track record of delivering specific customer requirements. We specialise in the formulation of all dosage forms and can advise on and develop bespoke offerings for our customers. Development and validation of analytical methods (to support new product development) are core competencies embedded in our processes. Supporting ICH stability studies can also be undertaken as part of customer requirements.

All contract research and development activity is underpinned by our quality management system. This guarantees a high level of quality and efficiency throughout all stages of product development. All outputs and formal reports are compliant in order to support regulatory submissions our customers may undertake. We adopt flexible approaches to contract research and development processes; therefore, customers may use their own protocols, or work can be undertaken following our protocols.

HPS also offers expertise and experience in technology transfer ensuring effective and efficient information transfer to our customers or their partners.

Our range of contract research and development services at a glance:

Formulation design and development

Analytical method development and validation

Analysis and testing of raw materials, intermediates, finished products

Drug product characterisation

Scale-up studies

ICH stability testing

Manufacturing

Labelling

Packaging

Regulatory advice

We offer investigators comprehensive advice and support in order to design and deliver clinical trials; be that for a one centre local study or a multi-national centred trial covering thousands of patients. Through a multi-disciplinary team based and client inclusive approach, we offer project management, technical advice and solutions in order to ensure efficiency of progress and to meet investigator timelines.

Our range of services to support customers through their clinical trials:

Dedicated and full Project Management capabilities stretching from initial with HPS to submission of results to regulatory authority.

IMP dosage form design, development and final formulation
Advice and recommendation regarding IMP container closures (and integrity)
Primary and secondary packaging of IMPs
Stability investigations and testing of IMPs (in-line with ICH guidelines)

Comprehensive advice on, writing of or review of clinical trial protocols
IMP dossier writing and submission to regulatory authorities
Investigator brochure preparation

cGMP batch manufacture of IMPs as required

Blinding of studies/IMPs
IMP sample retention
Qualified Person (QP) release of IMPs
Storage of IMPs
Inventory management
Forecasting and simulation
Distribution of IMPs to study centres
IMP destruction as required

Our range of clinical trial (IMP) manufacturing capabilities at a glance:

Sterile pharmaceuticals:

• Infusions
• Prefilled syringes
• Injections
• Ampoules
• Vials
• Eye-drops

Non-sterile pharmaceuticals

• Capsules
• Oral solutions and suspensions
• Externally applied liquids
• Creams
• Ointments
• Powders
• Suppositories
• Pastes

In circumstances where a patients clinical need cannot be met by a UK licensed medicine, clinicians may request to use a medicine that is licensed in another country.

HPS can provide a “one stop shop” for unlicensed medicines that includes capability to import medicines to be prescribed for patients in the UK. We directly liaise with global pharmaceutical companies or utilise a network of partners who can source medicines for importation. All medicines sourced (and manufactured) are covered by UK regulatory approvals and our comprehensive quality management systems and are supplied with certificates of conformance or certificates of analysis as appropriate.

We work closely with both NHS and pharmaceutical manufacturers in-order to source and stock customer required medicines covering over 15,000 product lines.

We are able to source both licensed and unlicensed items upon request.

Through our knowledge and experience we have the ability to tailor our service to your needs, offering you a simple and complete service.

We operate a fully equipped packing facility and operate multiple packing booths which permit the co-assembly of multiple batches whilst adhering to strict product segregation controls in-order to manage risks such as the prevention of cross contamination.

We source all medicines in-line with customer requirements, covering criteria such as brand type, pack size, expiry dates etc. and only release the product based on customer agreed product specifications which include (for example) labelling requirements.

Our range of tablet packing services at a glance:

Over labelling of all types of medicines and dosage forms

Re-packing of all types of medicines and dosage forms

No minimum order quantity

Dedicated Account Manager

HPS offer an effective and high quality Tablet Packing service that is bespoke to each customer.
For more details send us your enquiry.