Advanced Therapies

    Advanced Therapies

    Gsap is the leading consulting firm in the field of Advanced Therapies (Cell and Gene Therapies), with a unique portfolio of services aimed to support process development, preclinical, clinical and regulatory efforts. Gsap is well equipped to navigate clients through the rapidly evolving landscape of these products.

    Advanced Therapies LIFE CYCLE

    We are your partner from idea to market compliance!

    Product Development

    ATMP
    • Regulatory Strategy
    • Pre-clinical services
    • CMC services

    Pre IND/Scientific Advice

    • Preparing a Pre IND/Scientific Advice information package

    IND/IMPD

    • GMP facility establishment
    • QMS establishment
    • Writing the IND/IMPD
    • Pre-clinical &Clinical services

    Clinical Investigation

    • Clinical documents writing and amendment
    • Ongoing regulatory activities
    • Clinical Research Organization (CRO) services
    • Clinical Study Report writing

    BLA/MA

    • Support Technology Transfer
    • Process Validation
    • Methods Validation
    • BLA/MAA packages writing
    • Preparation for pre-approval regulatory inspections
    fda approved

    Regulatory

    Our team of regulatory experts has unique expertise in regulation of ATMPs with hands-on experience in development of products in the fields of: hematological malignancies, solid tumors, neuro-degenerative diseases (ALS, MSA, MS), cardio-vascular diseases, ophthalmology, tissue regeneration, muscular dystrophy, mitochondrial diseases, orphan/rare diseases and pediatric indications.

    Our ATMPs regulatory services include:

    ●Development of Regulatory Strategy

    ●Gap Analysis towards FIH or advanced clinical-stage studies

    ●Consultations with regulatory authorities (FDA, EMA, IMOH)

    ●Writing or reviewing regulatory submissions (e.g. IND, IMPD, BLA/MAA)

    ●Providing R&D support during the entire development plan

    quality assurance medical

    Quality (QMS)

    Gsap leads Quality Culture implementation through the product lifecycle – development, manufacturing, QC, batch release, transportation and patient treatment. We are equipped to provide quality compliance services as well as the strategy and training to help you improve your quality systems, thus mitigating future risks.

    Our Quality services include:

    ● Establishment of quality management systems (QMS)

    ● QMS assessment, maintenance and remediations

    ● Risk management according to ICH Q9

    ● Personnel training

    ● Client preparation for authorities GMP and pre-approval inspections

    cro

    Clinical

    With a high level of expertise in clinical affairs, we support phase I, II and III studies, leading to high quality clinical data as per ICH-GCP.

    Our clinical services include:

    ● Clinical development strategy

    ● Clinical documents writing (Clinical Protocol, Investigator Brochure, Informed Consent Form)

    ● Clinical documents maintenance and amendment

    ● Clinical Research Organization (CRO) services

    ● Clinical Study Report writing

     

    CMC

    Our experienced team helps companies leverage their minimal resources to execute the most efficient CMC (Chemistry Manufacturing Controls) plan, in compliance with regulatory requirements and industry benchmark.

    Our CMC services include:

    ● Establishment of GMP manufacturing process

    ● Technology transfer

    ● CMO selection and management

    ● Quality Control method development and validation

    ● Selection and sourcing of raw materials

    pre clinical studies

    Pre-Clinical

    Our pre-clinical experts can help maximize the potential for success by designing proof of concept (POC)/Safety/Biodistribution and Tumorigenicity studies that are appropriate to support the specific ATMP product and the selected regulatory pathway.

    Our pre-clinical services include:

    ● Pre-clinical strategy

    ●POC/Safety/Biodistribution/Tumorigenicity studies design

    ● Study protocol and report preparation

    ● CRO selection and study monitoring

    FDA audit

    Audits

    Quality and Regulatory audits are integral part of ATMP product lifecycle, assuring GMP compliance and readiness for product approval for marketing. Gsap provides a wide range of Internal and External audits, as well as client preparation for audits by 3 rd parties and regulatory authorities.

    Our audit services include:

    ●Internal quality audits for evaluation of the QMS in compliance with cGMPs

    ●External audits of CMOs, CROs, contract laboratories and raw materials suppliers

    ●Preparation for audits by regulatory authorities (FDA, iMOH, other)

    Global Submission

    Navigate your product development towards market compliance

    • USA

      FDA

      To facilitate ATMP development under FDA oversight, Gsap provides the
      following services:

      ●INTERACT and Pre-IND consultation
      ●IND filing and maintenance (amendments, annual reports)
      ●IRB submissions
      ●Regulatory meetings (Type A, B, EOP, C)
      ●BLA – Biological License Application

    • Canada

      Canada Health

      To facilitate ATMP development under Health Canada oversight, Gsap provides the following services:

      ●Pre-CTA consultation
      ●CTA submission
      ●IRB submissions

    • Europe

      EMA or local regulatory authority

      To facilitate ATMP development in EU, Gsap provides the following services:

      ●Scientific Advice (EMA and local authorities)
      ●IMPD filing and maintenance
      ●MAA – Marketing Approval Application

    • Israel

      IMOH

      To facilitate ATMP development under the Israeli MOH oversight, Gsap provides the following services:

      ●Early consultation with the IMOH
      ●Clinical Study Application with IMOH
      ●IRB (Hospital Helsinki committee) submissions
      ●Application for Marketing Approval