Quality & Compliance

We QC Everything

Whether a material comes from in-house manufacturing, crude material refinement, or trade, it is tested and must meet our specification standards and our quality must be in the good to excellent spectrum. Should there be a customer-specific quality concern, we actively look for a solution, even if the material is within our specifications.

Customer Audit statement

“During the review of the Quality Records it was observed that Biosynth had a clear understanding of how to maintain and control their records”

Excellent Customer Ratings

Our customer satisfaction surveys consistently receive high ratings.

ISO 9001 Auditor’s Report 2012

“Customer satisfaction resides in the center of business processes”

Brand Promise

If we ask our customers what they associate most with „Biosynth“, we always receive the answer “quality and consistency”.

Customer statements

“The quality of the material and the customer service is excellent”
“We never question the quality of products from Biosynth”

Beyond Product Quality

Consistently good quality in products and services are only achieved if the whole corporation masters all processes involved. We have been ISO certified for 20 years.“Biosynth’s management system based on its electronic document management is remarkable” (ISO 9001Auditor’s Report 2011)“An obligation to engage in continuous improvement can be felt on all levels“ (ISO 9001 Auditor’s Report 2011).

For almost 20 years we have been been a niche-API manufacturer. We have registered 2 Drug Master Files ourselves (DMF) and are audited regularly by the authorities. We are capable of offering services in the scope of method and process validation, DMFsubmission and support with marketing authorizations.

Customer GMP Audit

“The manufacturer commands a high level of expertise in synthetic chemistry and operates the necessary equipment.” 

Change Control

An increasing number of customers can’t solely rely on product specifications and the fulfilment of these specifications. They also need to control changes in specifications, changes in raw materials used or changes to the manufacturing process, even when the product is not an API. We comply with these requirements both with the products that we manufacture ourselves and with those that we refine or trade. While these requirements are more readily fulfilled with products that we manufacture ourselves, we aim to obtain sourced products from original manufacturers who we have a stable business relationship with and that we can audit, to assure a visible supply chain and information sharing for our customers.

Quality Control in China

Many manufacturers of potential interest in China offer their products at very good price points, but unfortunately there are often issues of varying levels with material and service quality. As soon as the material has left China, it becomes difficult to process complaints and for this reason we have established local quality control. Both samples and bulk materials pass to this partner facility first to undergo quality control testing under the strict supervision of our Swiss quality control personnel. Material will only leave China when released by our Swiss QC, saving precious time that can be otherwise utilized if obtaining an alternate source is required.

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