Frequently Asked Questions

FAQ / Frequently Asked Questions

Analytical services according to your needs

Galenica offers qualified pharmaceutical support aligned with current GMP and ICH guidelines. Our state-of-the-art equipment and expertise ensure seamless assistance at every stage of product development. Partner with Galenica for reliable and efficient pharmaceutical analysis.

General Information

We offer a flexible, client-centric approach, a broad range of expertise in various dosage forms, state-of-the-art facilities, and a proven track record of delivering high-quality pharmaceutical development services on time and within budget.

We specialize in oral, dermal, nasal, and pulmonary dosage forms, with expertise in small molecules and peptides.

We adhere to GMP, ICH guidelines, and pharmacopoeia regulations, and are audited and approved by the Swedish Medical Products Agency (MPA).

Simply contact us to discuss your project needs, and our team will guide you through the next steps.

Development & Manufacturing

Yes, we provide tailor-made formulations and specialized drug delivery systsems, including pediatric and geriatric dosage forms.

Yes, we manufacture clinical trial materials (CTM) in compliance with GMP regulations, ensuring high-quality production for Phase I to Phase III trials.

Yes, we have solid experience in technology transfer of our customers’ projects or products to actors for larger-scale manufacturing or commercial production.

Timelines depend on the project scope, but our flexible and streamlined processes ensure efficient and timely execution.

Yes, we provide GMP-compliant scale-up from preclinical batches to Phase III and commercial manufacturing.

Absolutely. Our facilities are designed to handle high-potency compounds (OEL: >0.03 μg/m³) and low RH compounds (<20%), ensuring safe and compliant manufacturing conditions.

Yes, we provide secondary packaging, labeling, and blinded clinical trial packaging, ensuring compliance with regulatory requirements.

Analytical & Quality Services

We provide a great variety of analytical services, amongst other, but not limited to; method development, formulation support, analysis for investigations, validation, forced degradation, stability studies, and QC testing using state-of-the-art analytical equipment.

We use HPLC/UPLC, LC-MS, FTIR, UV-VIS spectroscopy, rheometry, and particle size analysis, among other advanced analytical methods, to support formulation development, stability studies, validation etc. You find more information about our equipments and capabilities here.

Contact us

Contact us

Galenica provide tailor-made business solutions and offers unique flexibility for our clients, with possibilities to either choose single parts of our service or a complete drug development program.