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SARA Pharm Solutions - Contract Pharmaceutical Development Services for Small Molecule APIs

SARA Pharm Solutions is a private Contract Research Organization (CRO) specialized in solid-state pharmaceutics, pre-formulation and first-steps into formulation services. The company is located in the heart of the Romanian capital, Bucharest, in a newly renovated complex, Electromagnetica Business Park.

Making use of modeling tools to identify the most suitable solvents and excipients

SARA Pharm Solutions offers a comprehensive menu of specialized services, taking the Active Pharmaceutical Ingredient (API) drug substance through the stages of generating the first crystals, identifying the best (crystalline) solid form via extensive polymorph, salt or co-crystal screening and developing a robust crystallization process.

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SARA Pharm Solutions designs scientifically strong programs based on years of working experience of its scientific team. In all of its solid form screening programs, SARA Pharm Solutions makes use of modeling tools to identify the most suitable solvents and excipients to be taken into consideration with the drug substance under investigation.

Screening a broad and diverse parameter space in a short space of time

As a general as well as pragmatic view on the screening programs, with a minimal amount of API, SARA Pharm Solutions can screen a broad and diverse parameter space in a short space of time. Tailored experimental designs and crystallization modes yield an impressive throughput of conditions and results reported in a week or two.

The standard programs offered by SARA Pharm Solutions include:

  • Polymorph, salt and co-crystal screening;
  • Production, quantification and stabilization of amorphous phases;
  • Amorphous solid dispersion screening;
  • Pre-formulation studies (e.g. determination of solubility, dissolution rate - function of pH, pKa and logP/D determinations);
  • Stability studies on the drug substance (e.g. solid-state and solution phase stability, excipient compatibility studies);
  • Crystallization studies, crystallization process development and scale-up (max. 30-50g API);
  • Advanced analytical studies including: High throughput-XRPD, DSC, TGA, HPLC, NMR, IR, Raman, PLM;
  • Drug substance and Drug product characterization for formulation development (e.g. characterization of the solid forms in drug products such as tablets, capsules, semi-solids, suspensions)

In its on-going commitment to excellence, SARA Pharm Solutions has invested in a state of the art processing equipment and supporting analytical capabilities with the aim to identify and create new and improved drugs via solid state research.

An extensive track record of innovation and research contributions

Sara's management and technical team consists of both industrial and academic scientists with 5 decades of cumulative experience in US, Canada, UK and The Netherlands. They possess extensive track record of innovation and research contributions in solid state chemistry for pharma domain.

Sara's Quality Management System (QMS) has been recognized to be in full compliance with ISO9001:2008 standards, following an external audit carried out by Germanischer Lloyd Systems Certification. Sara's solid state studies are done according to and are in direct accordance with ICH Q8, 9 and 10 guidelines.

We will be happy to answer all your inquiries.

Contact

SARA Pharm Solutions S.R.L.
266-268 Calea Rahovei
Bucharest
Romania
RO-050912

Contact person:
Ioan Mihalcea - Chief Commercial Officer
Email: ioan.mihalcea@sara-pharm.com
Mobile:40-742.559.304
Tel: 40-312.28.3800;
Fax: 40-312.28.3802
www.sara-pharm.com