Consulting Services

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Consulting Services Products (107)

  • Product COMPLIANCE

    AUDITING: - Support its clients on Vendor Audit; COMMISSIONING:- Manages and performs commissioning activities for new systems, equipments and facilities; 
    TESTING:- Performs the following testing activities using its own instrumentation saving costs and time on tests planning; 
    COMP...
  • Product EU/UK Qualified Person (QP) Services and MIA license

    Conducting clinical trials or launching products for commercialization in Europe can be a challenge. There are many complexities that can impede your efficiency to these markets, such as establishing a legal entity with a Qualified Person (QP) in the region, Brexit, and passing inspections to sec...
  • Product GMP / QP Audits

    PharmSol carries out a complete chain of audits which assures product safety and quality to clients across the globe for Finished Products, APIs, Intermediates and Key Starting Materials (KSMs). PharmSol has an in-house team of Auditors who are accredited with various certifications including APIC/CEFIC/AS...
  • Product Validation

    Our team of experts will prepare necessary protocols incorporating all critical parameters


    Process Validation:

    PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...
  • Product Biocatalyst production

    Is the enzyme you are interested in not commercially available and a production needs to be developed? Enzymicals has extensive expertise with scale-up from lab to pilot-scale and technology transfers to industrial manufacturing sites. We can supply your protein by in-house production up to the kg-scale...
  • Product ANDA and NDA Technical Support

    As part of its commitment to full service support, Avéma Contract Services is pleased to offer our customers support with ANDA and NDA applications, including bio equivalency studies, collecting background data, supervising technology tranfers and reviewing applications to make sure that companies com...
  • Product IT/EU REGULATORY AFFAIRS - Support and management of RA practices

    OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
    Our expertise ranges from submission of registrations, variations, prices, texts, renewals (also via CESP), to CEP and...
  • Product CONSULTING SERVICES ON PARTICLE CHARACTERIZATION

    Consulting services which create value by combining our expert scientific background with highly qualified staff, equipments and facilities, to deliver advanced particle characterization studies such as:

    - Development validation and transfer of analytical methods

    - Comparative...
  • Product Custom Protein Synthesis

    We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
  • Product Data Integrity Assurance

    Data is a fundamental part of any Life Science production cycle and has become a major concern for global regulatory authorities.Choose PQE and ensure patient safety and business continuity within the entire product life cycle.
  • Product Business Development

    PharOS Ltd. offers a wide range of services which includes business development. Features: it provides new opportunities and growth potential to clients. The experienced managers continuously seek, identify and assess individual products and potential new markets. The broad network of professionals, locate...
  • Product Technical Services

    Complementing development sciences and clinical manufacturing, technical services include consultation on equipment specifications, scale-up, quality control, validation, and compliance auditing. On-site training is available in the fundamentals of lyophilization and validation.

      &nb...
  • Product Spray Drying - GMP, Cyto or Non-Cyto, Potent

    CritiTech's range of Spray Drying services is what sets it apart from other CDMOs. From Proof of Concept through GMP scale production. Dedicated Cytotoxic and Non-Cytotoxic SD equipment and facilities. Ability to process potent materials. Other key features include: • Spray-dried dispersions - API + polyme...
  • Product GxP Audits and Inspection Readiness

    Our auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections.

    Our team of specialists includes former regulatory agency inspectors and qualified auditors who are proficient in conducting mock inspections, internal audits...
  • Product Computer System Validation (CSV) Solutions

    ProPharma's validation professionals leverage the latest risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques to ensure that our clients' systems are ready for inspections from the FDA, EMA, MHRA, and other regulatory agencies. Our consultants have ext...
  • Product Hi-End Resource On Demand Solutions

    Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff....
  • Product Compliance Management

    PharmSol does not limit itself only to offering Audits, we expand our solution offerings to ensure complete Compliance at Client’s site. Towards obtaining GMP Certification from Europe or United States or WHO, PharmSol has a very effective, systematic and rationale approach in providing solution efficiently.
  • Product USFDA Compliance & Regulatory

    Preparing for a USFDA Inspection and managing the post inspection situation requires a high level of expertise and PharmSol offers a comprehensive solution in that direction.* Compliance Management * Product Development * Regulatory Support * BD Support
  • Product Regulatory & Market Access

    With the growth in pharma manufacturing capability in Asia, each manufacturer nurtures an ambition to have their own footprint in the EU market. PharmSol, with its own setups in Germany and Malta, has created a platform which provides a comprehensive, integrated and seamless market access and supply c...
  • Product Sourcing & Supply Chain

    Finding a right source meeting your desired specifications, compliance, expectations and commercial viability is a challenge.

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