// Indus­tries

Life Sciences & Pharma

Com­pa­nies in the phar­maceu­ti­cal and life sci­en­ces indus­try work within the con­text of important stan­dards and gui­de­lines set by regu­la­to­ry aut­ho­ri­ties such as the EMA and FDA. Com­pli­ance with the­se stan­dards places high demands on pro­ces­ses, pro­ce­du­res and docu­men­ta­ti­on. At the same time, com­pa­nies stri­ve to bring inno­va­tions to mar­ket safe­ly and quick­ly.

Stat­Soft sup­ports cus­to­mers in the deve­lo­p­ment and expan­si­on of solu­ti­ons and exper­ti­se, par­ti­cu­lar­ly in vali­da­ted sys­tem envi­ron­ments. We rely on advan­ced data analytics and AI solu­ti­ons to mas­ter the chal­lenges of the phar­maceu­ti­cal and life sci­en­ces indus­try.

We deli­ver added value to our cus­to­mers in various are­as and fields.

  • In rese­arch and deve­lo­p­ment, for exam­p­le, we pro­vi­de sup­port with tri­al plan­ning, the appli­ca­ti­on of gene­ral sta­tis­ti­cal methods and the cal­cu­la­ti­on of sam­ple sizes
  • In the field of pro­duc­tion, our exper­ti­se ran­ges from pro­cess ana­ly­sis, opti­miza­ti­on and moni­to­ring (CPV) to the imple­men­ta­ti­on of cross-site ana­ly­ses and reports.
  • For qua­li­ty assu­rance, we deve­lop effi­ci­ent solu­ti­ons for report­ing, with a par­ti­cu­lar focus on auto­ma­ted, vali­da­ted report­ing. In addi­ti­on, we spe­cia­li­ze in all neces­sa­ry reports in the are­as of pro­ducts, tren­ding, release and sta­bi­li­ty.

Related Content

The use of AI unlocks signi­fi­cant poten­ti­al for com­pa­nies in the phar­maceu­ti­cal and health­ca­re indus­tries. In this artic­le, we intro­du­ce some typi­cal and par­ti­cu­lar­ly wort­hwhile are­as of appli­ca­ti­on.
Vali­da­ted report­ing is cru­cial in phar­maceu­ti­cal pro­duc­tion to ensu­re GMP com­pli­ance and pro­duct qua­li­ty. Learn how Stat­Soft helps com­pa­nies crea­te auto­ma­ted, tam­per-pro­of reports while achie­ving effi­ci­en­cy gains.
Sta­bi­li­ty test­ing, also known as shelf-life assess­ment, stand as a pivo­tal stage in the phar­maceu­ti­cal deve­lo­p­ment, cru­cial for veri­fy­ing the iden­ti­ty, poten­cy and puri­ty of ingre­di­ents within a for­mu­la­ti­on. We explain how sta­bi­li­ty stu­dies can be imple­men­ted.
Many com­pa­nies in regu­la­ted indus­tries such as phar­maceu­ti­cal manu­fac­tu­ring or life-sci­en­ces are using Sta­tis­ti­ca suc­cessful­ly in the domains of qua­li­ty assu­rance & con­trol and pro­cess moni­to­ring.  We as Stat­Soft would in fact cla­im that the­se are the are­as whe­re Sta­tis­ti­ca deli­vers the hig­hest return on invest­ment. Why is that? 
We look for­ward to your enquiry.
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