The Santa Farma R&D Center carries out drug development activities in its 4 levels facility furnished with the state of the arts technological equipment. Built in 2015, the facility sits over an approximately 2,600 m² land in Dilovası. The R&D Center houses a pharmaceutical analytic development laboratory (instrumental analysis laboratory and wet laboratory), pharmaceutical laboratories, stability areas, and office spaces.

The team in the Santa Farma R&D Center includes pharmaceutical chemistry expert researchers, pharmaceutical technology experts and patent and clinic experts who have analytic thinking culture and are open to change, innovation, sharing and team effort. The science oriented team members hold bachelors, masters or doctorate degrees. They question the cause – effect relationship.

The development activities are performed for high value-added enriched products in various therapeutic fields under the Quality by Design (QbD) approach, which emphasizes product quality, and in line with the global scientific guidelines (US – FDA, EMEA, WHO, ICH), and all updates are reflected in the activities.

OUR WORK AREAS

As a One Stop Shop with TR and EU approved commercial production areas, our R&D Center offers the advantage of providing all professional services to its domestic and international partners. In general, our EU based work areas include the following:

• Patent Screening and Assessment
• Raw Material Characterization and Pharmaceutical Analysis
• Pharmaceutical Product Development For All Dosage Forms
• Analytical Method Development, Optimization and Validation
• Laboratory Scale and Scale – Up Productions
• Process Optimization and Validation
• Laboratory and Formal Stability Studies
• Bioequivalence and Clinical Studies
• Technology Transfer Studies
• Joint Development Activities
• Public Sector – University – Industry cooperation activities
• Documentation of license files in CTD format, which is accepted in international sector.

DOSAGE FORMS WHICH CAN BE DEVELOPED IN OUR R&D CENTER

Solid Dosage Forms

• MR, SR, DR, XR, IR, ODT, DT Tablet Pharmaceutical Products
• DR, SR Pellet
• Pastille, Chewable Tablet
• Capsule
• Granule Suspension
• Effervescent Granule, Tablet

Liquid Dosage Forms

• Syrup
• Suspension
• Injectable
• Spray (dermal, nasal, and oral)

Semi – Solid Dosage Forms

• Ointment
• Cream
• Lotion
• Gel

OUR DIFFERENCE

• The largest Pharmaceutical Products R&D Center in Turkey; the 4 levels center is situated on a 2600 m2 land and was accredited in its 1st year of opening.
• An expert and dynamic team, that almost have “know-how” on product development on almost all therapeutic fields and dosage forms
• Product development in solid (Pellet, Effervescent, and Multi Combination products), semi – solid and liquid dosage forms with advanced infrastructure and technical possibilities
• A “one stop shop” integrated modern production facility, which has been approved by European Union
• The potential for project development and export to GCC, CIS, MENA, and Far Eastern countries in addition to Europe and the USA
• Bioequivalence and Clinical Studies managed by international guidelines
• Fast and efficient project development thanks to time and cost oriented work principle and alternative solution suggestions
• Analytical and formulation process optimization activities intended for decreasing cost of product
• Fason and In-House Product Development Activities for Domestic and International companies under the Quality by Design (QbD) approach in accordance with the ICH/FDA/EMEA guidelines.

OUR INFRASTRUCTURE AND WORKING ROUTE

The Pharmaceutical Technology and the Pharmaceutical Analytical Development laboratories of the Santa Farma R&D Center are furnished with the state of the art technology equipment of the globally known brands and designed to carry out safe product development activities.
In product development activities of the Santa Farma R&D Center;
The following activities are performed based on full project management subsequent to Product feasibility, Literature, Clinical and Patent assessments:

Our Pre-formulation Studies:

• Raw Material and Auxiliary Product Research
• Raw material characterization
• Different media dissolution studies
• Raw material – Auxiliary product compatibility studies
• Formulation and package compatibility
• Dissolution rate media studies and optimization
• Reference product Characterization

The objective of the pre-formulation studies jointly performed with the Santa Farma R&D Center is to carry out the studies quickly and in a controlled manner with an intention to obtain detailed information about the active matter (API) and the product.

Pharmaceutical Technology Product Development Studies:

• Dosage Form Development
• Product Development Under the Design and Quality Approach
• Laboratory, Scale Up – Scale Down Studies
• Optimization and Risk Development
• Pilot Process Validation
• Stability

Santa Farma R&D Center adapts risk based, efficient and effective, cost based, feasible, quality, enriched, and stable pharmaceutical and therapeutic equivalence work principle which increases patient compliance.

Bioequivalence – Bioavailability Studies:
The Santa Farma R&D Center performs its clinical studies with reliable domestic and international CROs that are approved by EMA and US – FDA.