Our Business Model

Lab man goggles

The combination of Bespak and Aesica allows the Group to provide a broad, clear and integrated drug/device service offering to pharmaceutical customers.

Bespak Division

Bespak's business model is built to support two principal goals:

  1. Helping our customers succeed in commercialising their own designs of drug delivery devices; and
  2. Developing proprietary designs of drug delivery devices for sale to blue-chip pharmaceutical and Life Sciences customers.

To this aim, Bespak has and will, continue its diversification of the drug delivery segments in which it operates, as well as increasing its share of the value-added content in the supply chain.

To date, Bespak has evolved the range of drug delivery opportunities from its origins in the respiratory segment to that of injectables, nasal, ocular and POC diagnostics. Bespak has also further enhanced its share of the value added in the supply chain beyond that of product design, development, industrialisation and commercial manufacturing operations, and into the handling of drugs for the purposes of clinical trials and commercial market release on behalf of its customers.

Bespak has developed significant core capabilities, competencies and processes developed through strategic investments in skills, technologies and infrastructure that provide for the best long-term growth and profitability prospects based on the value they deliver to our customers, whether based on either customer-owned or Bespak-owned Intellectual Property.

Aesica Division

Aesica's business model has, historically, been built on four key pillars:

  1. Strategic partners;
  2. Geography;
  3. Technology; and
  4. Organic growth.

Aesica considers strategic partners to be those where there is potential to create significant revenues across the Aesica network. As the industry is shifting towards supply chain consolidation, Aesica focuses on the retention and formation of strong partnerships with global pharmaceutical companies, generics companies and regional players through new business development and key account management.

Our intention is to continue to achieve organic growth by building on Aesica's foundations of new business development, key account management, project management and continuous improvement as well as broaden our technology offering through both acquisition and innovation.

Group

Both Aesica and Bespak are pharmaceutical services businesses with virtually identical target customer bases. Whilst the divisions have several customers in common, currently, a number are exclusive to either Aesica or Bespak. The combination of two such complementary pharmaceutical services providers allows the Group to provide a significantly broader, deeper and more integrated drug/device contract manufacturing and supply chain solution to its customers.

As well as driving the individual Aesica and Bespak divisions, as a larger pharmaceutical services company, the Group's business model is to offer existing and prospective new customers a single source supply chain solution for drug and delivery device development, formulation, manufacturing and packaging. Optimising drug and device services in a single group streamlines and accelerates the route of drugs to market and reduces the cost and complexity of drug/device development for the Group's pharmaceutical partners.

Consort Medical's Core Capabilities

With both divisions operating in highly regulated environments where quality and reliable manufacturing are paramount, there is a significant alignment of Bespak's and Aesica's respective skills and competencies.

Significant Alignment of Core Competencies between Aesica and Bespak

Quality

Quality Management

Offers a complete range of quality services from QP release and EU/EEA importation to qualification and validation.

Quality Management System (QMS) which is certified as conforming to ISO 13485.

cGmp

Five CGMP manufacturing plants dedicated to commercial-scale production of APIs manufacture and packaged finished dose products.

Compliant with FDA CFR 21 parts 210 & 211 CGMP and FDA CFR 21 part 820 Quality System Regulation.

"Best in class"

Significant investment in facilities and technology ensuring “best in class” quality and reliability.

Dedicated “Lean Manufacturing” team focused on the supply chain with the goal of improving processes and operations and eliminating non-value-added activities.

Regulatory Compliance

FDA

All company’s API facilities are inspected and approved by FDA as well as main manufacturing sites.

A mature ISO 9000 accreditation and an FDA 21CFR820 compliant quality system.

MHRA

All manufacturing sites are approved by MHRA and sites supply product worldwide to high CGMP manufacturing standards and requirements.

Manufacturing and supply operate to ISO 13485, the MHRA standard for medical device manufacture.

Environmental health and safety

Secure facilities to handle up to schedule 2 controlled substances. Also a high containment suite to manufacture products in the SafeBridge® Category 3 level of potency.

ISO 14001 accreditation relating to environmental compliance.

Reliable Manufacturing

Complex

Capabilities include continuous, high capacity, high potency and innovative continuous manufacturing.

One of only a handful of operators globally who have the process know-how and expertise to consistently deliver Six Sigma quality on such a high volume of components and devices.

Pilot up to volume manufacturing

Ability to operate at scales from grams to full commercial scale.

Low volume hand machined production through to high volume assembly. Operates to ISO 13485 and holds clinical trials and commercial drug handling licences. >30 audits p.a..

Continuous improvement

Continuous Improvement tools underpin all operations within Bespak and Aesica.

Quality

Quality Management

Offers a complete range of quality services from QP release and EU/EEA importation to qualification and validation.

Quality Management System (QMS) which is certified as conforming to ISO 13485.

CGMP

Five CGMP manufacturing plants dedicated to commercial-scale production of APIs manufacture and packaged finished dose products.

Compliant with FDA CFR 21 parts 210 and 211 CGMP and FDA CFR 21 part 820 Quality System Regulation.

"BEST IN CLASS"

Significant investment in facilities and technology ensuring “best in class” quality and reliability.

Dedicated “Lean Manufacturing” team focused on the supply chain with the goal of improving processes and operations and eliminating non-value-added activities.

Regulatory compliance

MHRA

All manufacturing sites are approved by MHRA and sites supply product worldwide to high CGMP manufacturing standards and requirements.

Manufacturing and supply operate to ISO 13485, the MHRA standard for medical device manufacture.

Environmental health and safety

Secure facilities to handle up to schedule 2 controlled substances. Also a high containment suite to manufacture products in the SafeBridge® Category 3 level of potency.

ISO 14001 accreditation relating to environmental compliance.

FDA

All company’s API facilities are inspected and approved by FDA as well as main manufacturing sites.

A mature ISO 9000 accreditation and an FDA 21CFR820 compliant quality system.

Reliable Manufacturing

Complex

Capabilities include continuous, high capacity, high potency and innovative continuous manufacturing.

One of only a handful of operators globally who have the process know-how and expertise to consistently deliver Six Sigma quality on such a high volume of components and devices.

Continuous improvement

Continuous Improvement tools underpin all operations within Bespak and Aesica.

Pilot up to volume manufacturing

Ability to operate at scales from grams to full commercial scale.

Low volume hand machined production through to high volume assembly. Operates to ISO 13485 and holds clinical trials and commercial drug handling licences. >30 audits p.a..

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