Reasons to work with NIPCOS

More than 20 years of experience with very impressive results

High level of authority acceptance (e.g. Swissmedic, FDA)

Worldwide experience with proven results (e.g. FDA & EMEA)

Highly rationalized and professional solutions & operations

Tailored solutions integrated into your system

Competent partner for all stakeholders

Our team consists of pharmacists, chemists, physicians and patent layers. Their expert know-how is fully available to solve your problems using critical experience. They act as consultants to you and are specialized in the fields of drug development, regulatory affairs, Quality (GMP / GDP / GLP / GCP ) and clinical studies.

Our consultants act as Qualified Persons on behalf of pharmaceutical companies in Switzerland. Our Regulatory Affairs Consultants liaise directly with Swissmedic, EMEA or FDA and execute their regulatory affairs work in drug development or quality projects.

Proof of concept studies, pharmacokinetic studies, IND FIM & PET studies, sterile products and radiopharmaceuticals are areas where our specific expertise is highly valued and applied. NIPCOS is moreover working in close cooperation with Research Institutes and Universities such as ETH Zurich.

Our consultants successfully and repeatedly guide Swissmedic, EMEA MRP, FDA NDA & ANDA marketing applications and prepare CTD, CTA, DMF, IMPD well accepted dossiers.

Our GMP consultants lead authority inspections such as FDA pre-approval inspections or Swiss authority inspections and escort our customer companies through to successful completion of these inspections.

NIPCOS consultants participate in and guide international product development teams and have developed 3 world marked leader products with an annual turnover of 5 billion SFr. from own invention to marketing authorisation.