From R&D to clinical trials

Plan, lead, and drive forward development work

We provide project management and control of internal and external development tasks.

Evaluation of process and product requirements 

We show you the risk-based path to a safe and requirement-compliant specified product. We accompany you in the necessary target definition of the product-specific quality requirements (quality target product profile, QTPP) and set up the GMP-compliant manufacturing process.

Derivation and definition of characteristic process parameters

You specify the process flow; we guide you in defining and planning the necessary investigations. You will get a detailed process understanding and definition of the critical quality attributes (CQAs), the critical process parameters (CPPs), and the critical performance parameters (CPerfPs).

Process control strategy and appropriate limits 

We support you in defining the control strategy for the critical quality attributes and product specifications and define the parameter corridor (design space) for process control.

Analytics and sampling

We guide you in selecting and defining the analytical methods derived from the process control strategy. We further describe the correct sampling and prepare the documentation required for system suitability, verification or validation.

Quality control

You specify the methods - we generate the test instructions and protocols for your methods.

Batch documentation 

You provide the instructions - we create the master batch record (MBR).

Process risk analysis and validation

We accompany you with iterative risk analyses from the complete process characterization to the definition, documentation, and implementation of the required validation activities.

Manufacturing studies and development history

You want to complete the development of your manufacturing process? We compile the results of your own development and the data available in literature in a professional documentation, the overall process development summary.

Process transfer to contract manufacturer

We offer the search, selection, and qualification of a suitable manufacturer. Furthermore, we accompany you in contract negotiations, in the delimitation of responsibilities, and in a securely documented process transfer.

We prepare the necessary GMP documentation for you and write the quality manual handbook (QMH), quality risk management instructions, binding master files, the site master file (SMF), the validation master plan (VMP), and the hygiene master plan (HMP) according to the standard of your industry sector.

Find out more about the Valicare GMP services, our special consulting services tailored to the GMP manufacturing of active pharmaceutical ingredients and medicinal products here.

Supplier qualification

You want to ensure the pharmaceutical quality of your suppliers? We implement the qualification concept of your GMP system, create the relevant planning, and carry out graduated qualification measures (if required on a risk basis) from obtaining certificates to on-site supplier audits.

You want to build a manufacturing plant yourself quickly, inexpensively, and in compliance with the authorities? Together with Syntegon, we are your one-stop shop for planning, construction, equipment, and ready-to-operate installation of your application for manufacturing authorization according to § 13 AMG pilot facility, including all necessary qualification and validation services.

You want to apply for a manufacturing authorization yourself? We will assist you quickly and efficiently in generating the application documents, submitting them in the correct form, and communicating with the authorities.

You need support and management personnel to realize your GMP-compliant manufacturing of investigational medicinal products on time and according to requirements? We help you to find personnel, provide pharmaceutical management functions in a transitional period, and manage the GMP-compliant operation of the facility until you take over with your own personnel.

This includes the key pharmaceutical personnel (qualified person, QP; production officer, PO; head of quality control, head QC; head of quality assurance, head QA; head of engineering and maintenance) and start-up of the manufacturing facility under GMP conditions.

Investigational medicinal product management and investigational medicinal product dossier (IMPD)

You are looking for support in preparing, organizing, and logistics of international multi-center clinical studies? We advise you on the selection of study sites, organize the procurement of GMP-compliant placebo and comparator medication, take care of the generation of country-specific documentation and package inserts, carry out packaging, repackaging and blinding processes with suitable advance arrangements, and organize transport including the necessary import/export permits including country-specific approval.

But that's not all: Our team will be pleased to help you with further requirements arising from approval or authorization procedures, in setting up market supply, in organizing logistics and medicinal product transport in cooperation with our market-leading partners.