Services

Established in 2002 by Professor Mike Rubinstein, Orwell Pharmaceutical is an indepedent, privately owned company with the scientific expertise to respond flexibly to each new challenge, and give every project the best possible chance of a successful clinical trial.

What We Do

At Orwell Pharmaceutical our job is not simply to find an effective method of drug delivery for each new product, it is to find the best and most effective method possible. Our comprehesive, flexible range of services enables clients to bring drug products through the various stages of clinical development, from pre formulation work to formulation, dosage form design and optimization.

HOW WE WORK

We believe in direct communication, honest dialogue, and collaborative working, confidentiality is absolutely assured in every aspect of our services,

HOW WE WORK

We believe in direct communication, honest dialogue, and collaborative working, confidentiality is absolutely assured in every aspect of our services, from your first enquiry onwards

Our in-house scientific expertise enables us to approach every project from the most fundamental principles, thoroughly researching your drug and building a complete understing of it posible results. we understand the importance of cost and timelines, and make sure that these factors are clearly set out and agreed at the outset.

while our aim is to meet your immediate requirements, we always look ahead to ensure that the short-run manufacturing we can easily be scaled to commericial quantities or licensed to another party.

our working practice is to agree a fee for each stage of our service, in advance. we will not tie you in to formulations or technologies that will reduce your options. our work, once paid for is yours without futher commitment.

ANALYTICAL SERVICES

Orwell Orwell Pharmaceutical , has hugely experienced analytical specialists working alongside our formulation and manufacturing teams which provide expert advice and an enormous breadth of advanced anlytical technologies. their contribution is a vaital factor of our success in early stage formulation development, stability studies and clinical trial manufacture.

Analytical & quality control services include:

  • Analytical method transfer, development and validation
  • stablity indcating assays using UPLC and HPLC (including forced degradation studies).
  • Formal and informal stability study design, storage and testing
  • Batch release and raw material testing
  • chemical and physical testing
  • chiral analysis
  • dissolution testing and drug release profiling

LABORATORY FACILITIES

Orwell Orwell Pharmaceutical, our clinical manufacturing areas all meet the standards set out in the good manufacturing practices criteria, and have been audited and accredited by the medicines and healthcare products regulatory agency (MHRA). we also hold a manufacturing authorisation for the manufacture and testing of investigational medicinal product (IMPs), including medical devices, as specified by the EU clinical trials directive (2001/20/EC).

Significantly, we are also one of the small number of companies licensed by the MHRA to carry out specials manufacture. specials are unlicensed medical products produced to meet the particular clinical requirements of individual patients whose needs cannot be met by lincensed medicines.

We have the capacity and necessary licences to handle controlled drugs and, because we supply a large volume of clinical trial products to North America, we are registered with the FDA following a successful establishment inspection of the Orwell Orwell Pharmaceutical facility.

LIVE BIOTHERAPEUTICS DRUG DELIVERY

Orwell Orwell Pharmaceutical is experienced in the formulation development and is one of the few companies licensed for the clinical manufacture of live biotherapeutics being targeted for digestive, urogenital, otorhinologic and pulmonary delivery.

Understanding the client dosing requirement for the live biotherapeutic, quay can prepare a formulation development strategy to bring it rapidly and effectively to first in Man (FIM) studies and on to further clinical use aiming to provide a formulation with the best chance of clinical outcome. our formulation development and clinical services include

  • Immediate release and controlled release tablets
  • multilayer tablets
  • Oral multiparticulates such as beeds, pellets and mini-tablets

PREFORMULATION

Orwell Orwell Pharmaceutical , we highly experienced in preclinical formulation and anlysis of active pharmaceutical ingredients (API), including those that present particular challenges.

we regularly help early stage companies to evaluate the physicochemical properties of their new drug, carrying out the essential groundwork for optimising the formulation and delivery method. we can then create a product that is appropriate for your needs, whether you require a fit for purpose formulation for initial preclinical safety and efficacy testing or a formulation strategy designed to help your drug progress into clinical use.

Our Preformulation capabilities include:

  • API stability profiling (including an evaluation of the effects of heat, light, and pH).
  • Com
  • patibility testing of APIs and excipients.
  • Tablet compaction analysis.

Address

UNIT B-D, CROWN BUSINESS PARK, DUKESTOWN, TREDEGAR NP22, UNITED KINGDOMS

HOURS

  • FRIDAY 6AM-10PM
  • SATURDAY (CLOSED)
  • SUNDAY (CLOSED)
  • MONDAY 6AM-10PM
  • TUESDAY 6AM-10PM
  • WEDNESDAY 6AM-10PM
  • THURSDAY 6AM-10PM

+448712459778