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MedPharm Ltd

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4 Orders Completed
Guildford, GB

About MedPharm Ltd

MedPharm is the world’s leading contract provider of topical and transdermal product design and development services.  We are a full service CDMO specializing in semi-solids providing development services from formulation development through GMP clinical manufacturing.  MedPharm, recognised for their scientific rigour by regulators and investors alike, are experts at reducing risk and accelerating development times through their unique cost-effective performance testing models.


Over the last 20 years, MedPharm has supported the development and approval of 55 marketed products around the world including the U.S., Europe, and Japan.

Our Services (17)


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Buccal Absorption Studies

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Human Psoriasis-Like Epidermal Hyperplasia Model

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In vivo Skin Irritation/Sensitization Testing

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Analytical Method Development

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Reverse Engineering

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Transdermal/Transmucosal Drug Delivery Systems

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Inhalation Product Development

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Ophthalmic Drug Development

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Topical Formulation

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MedPharm has more than 20 years experience developing topical and transdermal formulations.  We can begin as early as API screening and we support pre-formulation activities, lead formulation selection, formulation optimization and reverse engineering.  We have had a role in taking over 55 products to market.  We partner with large and small companies in the cosmetic, OTC, Rx and medical device industries to de-risk their early development activities to develop formulations that meet target product profiles.  

Respiratory Cosmetics Dermatology Inflammation Ophthalmology Rare Disease Pharmaceutical Women's Health and Prenatal Care Show 8 more tags Show less

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Drug Release Studies/In Vitro Release Testing (IVRT)

Price on request

MedPharm leverages its 20 years of experience to help develop and validate IVRT methods for its clients. We successfully perform IVRT based on FDA and EMA guidelines and continue to influence how these methods are utilised in regulatory submissions.

IVRT is the established method recognised by regulators, and is commonly used for measuring the release of the active component(s) from semisolid products. Regulators are increasingly requiring validated IVRT methods as part of product release and stability specification.



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In vitro Disease Models

Price on request

When trying to de-risk a clinical trial decision it is highly desirable to establish that the active drug is not only getting to the site of action but is also bio-available and having the expected impact on a relevant biochemical pathway.

By leveraging our expertise in immunology, skin biology, microbiology, and tissue engineering, we have helped many clients mitigate risk using performance models. These models are also known as pharmacokinetic/pharmacodynamic (PK/PD) models because they give a readout of where the drug permeates alongside a measure of biological activity.


MedPharm has used these PK/PD models to directly help clients:

Mitigate risk in programmes prior to making expensive clinical decisions

Inform API selection, dose ranges, posology, and formulation optimisation

Assess new targets and technologies for local activity

Achieve biowaivers for generics by showing equivalence with the originator product

Support marketing claims and educate key opinion leaders


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Process and Scale-Up Chemistry

Price on request

Our process development experts are uniquely placed to predict and mitigate risks during the scale-up of the formulation. This is critical to achieving consistent product performance and quality at a stage of fundamental importance on the road towards commercialisation.

Process development aims to establish optimal manufacturing conditions for a pharmaceutical product and ensure that it meets both quality and regulatory standards. MedPharm’s long experience in scale-up has shown that investigating early in understanding the process can prevent potentially expensive issues occurring during the supply of clinical batches and also when starting commercial supply.

MedPharm uses the Quality by Design (QbD) principles outlined in ICH Q10 in the design and scale-up of any formulation. Combining an understanding of a product’s Quality Target Product Profile (QTPP) and subsequent Critical Quality Attributes (CQAs) with MedPharm’s many years of experience our scale-up team will recommend an efficient set of small scale experiments to test the sensitivity of the product to any Critical Process Parameters (e.g. mixing rate, cooling rate etc) they have identified. The data maps out any critical limits of these parameters and ensures that subsequent batches can be made with consistent quality.



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Semisolid Manufacturing

Price on request

MedPharm manufacture batches for toxicology testing and clinical trials and can create registration batches for generic submissions. At this point the MedPharm team will be very familiar with the formulation and continuing to full-scale manufacture within the same team eliminates any potential for continuity errors that could impact a project’s commercial milestones.

Our teams have significant experience in filling, packaging, labelling and despatch of all formulation types, ensuring they are ready for use in clinical trials worldwide. Investigational product management services offered by MedPharm ensure an end-to-end service which complements the client’s clinical research activity.

Our GMP accredited facilities are capable of manufacturing all topical formulation types including liquids and semi-solids in batch sizes up to 100 kg.


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ICH Stability Testing

Price on request

Stability indicating methods are established early in the development process and can be appropriately validated for full-scale batch testing.

In order to simplify the compilation of a client’s regulatory submissions, all data is provided in IMPD/IND/CTD format. MedPharm can do stability testing in all ICH zones.


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In vitro Bioavailability/Bioequivalence Studies

Price on request

The regulatory landscape for generic topical products has significantly evolved in recent years. Opportunities are opening in the USA and Europe for generic approvals by demonstrating in vitro bioequivalence, as opposed to utilising the risky and expensive clinical bioequivalence route.


MedPharm has led the way in pioneering this approach. We support our clients by producing credible data and presenting reliable arguments to regulatory authorities during scientific advice and pre-ANDA meetings.


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Ex Vivo Disease Models

Price on request

When trying to de-risk a clinical trial decision it is highly desirable to establish that the active drug is not only getting to the site of action but is also bio-available and having the expected impact on a relevant biochemical pathway.

By leveraging our expertise in immunology, skin biology, microbiology, and tissue engineering, we have helped many clients mitigate risk using performance models. These models are also known as pharmacokinetic/pharmacodynamic (PK/PD) models because they give a readout of where the drug permeates alongside a measure of biological activity.

MedPharm has used these PK/PD models to directly help clients:

Mitigate risk in programmes prior to making expensive clinical decisions

Inform API selection, dose ranges, posology, and formulation optimisation

Assess new targets and technologies for local activity

Achieve biowaivers for generics by showing equivalence with the originator product

Support marketing claims and educate key opinion leaders


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In Vitro Permeation Testing (IVPT)

Price on request

MedPharm offers its customers options for IVPT, including our unique MedFlux-HT® automated flow-through system or classic static cells.

IVPT is used to measure the permeation and penetration of a drug through tissue and is an essential tool for optimising topical and transdermal formulations. This is because a drug’s ability to permeate any tissue is very dependent on the quantity and quality of the excipients used. It cost-effectively provides a measure of performance of a product using human tissue and removes the uncertainty and ethics of working with ex vivo animal models.


IVPT is a cost-effective method used to demonstrate:

The optimisation and characterisation of formulation performance

De-risking clinical trial decisions

Product performance to potential investors

The bioequivalence of a generic compared to an originator product

New marketing claims to educate key opinion leaders


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Daniel Morland

Senior Business Development Manager

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