The global pharmaceutical industry is witnessing rapid advances in processes and technology, and automation is emerging an integral part of most manufacturing processes. With stricter regulatory norms and spiraling costs, pharmaceutical companies are opting to outsource their manufacturing process to contract manufacturer in order to improve efficiency and productivity. In catering to this growing demand, contract manufacturer are offering strategic value-added services such as process development, marketing support, process optimization, and life cycle management, thereby integrating themselves in the supply chain of the pharmaceutical companies.

 

 

Benefits of outsourcing services are well known by the pharmaceutical industry:

 

-      Reducing time to market. The time to market of a particular product is one of the key underlying factors behind the profitability of a company. In the pharmaceutical industry, a delay of even a day while getting a product to the market can cost the company millions of dollars. As a result, achieving the quickest possible time to market is a key challenge for companies. Contract manufacturer strive to address this challenge.

-      Optimizing the supply chain. One of the key challenges to achieving competitiveness in the pharmaceutical industry is the management of the supply chain. The pharmaceutical supply chain can be optimized by utilization of the services of contract manufacturer.

 

-      providing a back up position;

-      reducing risk and debt;

-      providing expertise;

-      providing equipment and flexibility (relieves manufacturing constraints);

-      providing cost control;

-      allowing focus on core activities (refocusing organisation, re-engineering processes, accommodating business downsizing needs, focusing on business-critical tasks);

-      providing improved operational quality (increased expertise, benefits from the core business expertise of specialised partners);

-      allowing improvement of productivity (economies of scope, increased flexibility, improve time-to-market); and

-      providing control of business risk (increased access to diverse technologies, access to technologies without capital investment, reduced technical obsolescence risk).

 

Pharmaceutical companies have to select the best outsourcing partner for satisfying their needs – a poor choice could cause delays and quality problems and even jeopardise regulatory approval. Issues to consider include:

 

-      commitment to quality;

-      meet best practices and standards for GMP;

-      flexibility;

-      reputation;

-      client references;

-      well-trained and experienced staff;

-      validated systems and processes;

-      therapeutic experience;

-      staff background;

-      experience with new technologies;

-      costs including capital and tooling costs;

-      price;

-      location ease of interaction;

-      financial stability;

-      technology transfer capability;

-      responsiveness to customer demands; and

-      cultural fit

 

A number of pre-conditions, features and capabilities are inevitable to successfully running a business. The key deciding factors are outlined below:

 

-      Mutual trust and respect.

-      High priority for a project.

-      Clear, concise and well established rules.

-      Open an efficient communication (required for the success of any contract relationship → face to face meetings during the whole activity, conference calls, e-mail, etc.).

-      Rational cost.

-      Scientific expertise.

-      Regulatory documentation (protocols, format, type and date of presentation) defined and approved by client prior to starting the project.

-      Flexible contract template for an easy agreement that is not time-consuming (it can take months to sign a contract because negotiations for terms and conditions usually stretch out the longest).

 

Nonetheless, in the outsourcing business, innovation is the key to growth. Few contract manufacturers offer innovation to their clients, Unither Pharmaceuticals ® is one of them.

 

Unither is a contract manufacturer focused on the development and manufacture for its clients.

Unither is an independent pharmaceutical company specializing in the design, development and custom manufacture of the pharmaceutical presentations that patients and prescribers prefer:

Unither undergoes regular inspections by national and international health authorities. It is compliant with European cGMP guidelines and has achieved ISO 13485 certification.We export to over 65 countries and attach great importance to the quality of the customer service.

 

Our clients have the commercial skills and resources to market theirs products under their brand with success. We make their products innovative.