PharmSol Group

About PharmSol Group

With 15 years in the pharma industry, PharmSol has excelled in providing a spectrum of services which fulfill the needs and aspirations of Pharma Manufacturers and Marketers across the globe. The services being provided by PharmSol cover the expanse of pharmaceutical business, encompassing EUGMP Certification, USFDA Inspection, WHO / PICs Certification, GMP/QP Audits – API / KSM / Excipient / PM, GDP Certification, CRO Approvals, Trainings, Tech Transfer, Product Development – Co-Development / Contract Development, BE Studies, EU Regulatory & Market Access, US ANDAs; DMFs & Market Access, CEP Filing – API / Excipients, Serialization, Facility Design & Upgradation, Facility Commissioning, Qualification & Validation (CQV), Sourcing & Supply Chain, Strategic Alliances; Acquisitions, Portfolio Expansion among others, with a focus on EU, US and other International Regulatory Compliance. With direct presence across Europe, Asia and Middle East, PharmSol offers integrated solutions with ‘single window’ access to all its clients. This ensures seamless and timely deliverance on all assignments.

  • MT
  • 2015
    On CPhI since
Consultancy
Contact info

Products from PharmSol Group

  • GMP / QP Audits

    Product GMP / QP Audits

    PharmSol carries out a complete chain of audits in compliance to EU GMP, US, ICH requirements. PharmSol is one of the biggest third-party auditing organizations. The Auditors of Team PharmSol are accredited with various certifications including APIC/CEFIC/ASQ and ISO. •GMP Audits  •Bulk Audits   •Shared Audits   •GDP, GLP, GCP Audits  •EHS Audits  •Quality Due Diligence
  • Compliance Management

    Product Compliance Management

    PharmSol does not limit itself only to offering Audits, they expand their solution offerings to ensure complete Compliance at their Client’s site. Towards obtaining GMP Certification from Europe or United States or WHO, PharmSol has a very effective and efficient solution. PharmSol operates on a turnkey basis and gets involved completely ensuring success. •EU, AU, WHO, PIC/s GMP Certification  •CAPA Support  •Computer System Validations  •Data Integrity Solutions   •Serialization   •GDP Certification   •GxP Training
  • USFDA Guidance

    Product USFDA Guidance

    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.  •Gap Analysis Audits  •CAPA Guidance / Assistance  •Training for Inspection  •Post Inspection Remediation (483s / Warning Letters) •Ongoing compliance monitoring  •US ANDA Preparation & Submission
  • Sourcing & Supply Chain

    Product Sourcing & Supply Chain

    Finding a right source meeting your desired specs, compliance, expectations and commercial viability is a challenge. PharmSol, with its global reach, is able to facilitate provision of validated and long term sustainable sources.  •APIs, KSMs  •Finished / Semi Finished Formulations  •Excipients / PMs •Vendor Qualification  •Technical & Commercial Negotiations  •Pre-shipments Inspections / Approvals  •Supply Chain Management
  • Regulatory & Market Access

    Product Regulatory & Market Access

    With the in-house regulatory expertise and direct presence of PharmSol through its offices in Europe, PharmSol provides an end to end, single window solution to register and market the product in USA, Europe, Australia and Middle East. •Dossier Preparations / Submissions  •Pharmacovigilance  •MA Holding  •EU Importation, Batch Control / Release •Scientific Advice  •GCC Product / Company Registration, Marketing & Distribution
  • Product Development

    Product Product Development

    PharmSol provides a complete package of services for development and commercialization of any product be it Active Ingredients or Finished Dosages. PharmSol assures success in bio-equivalence. •Product Developments (API & FDF) •Patent Evaluation  •Tech Transfers  •Scale ups •BE Studies   •Licensing In/Out
  • Facility Design &  Project Management

    Product Facility Design & Project Management

    PharmSol has a dedicated team of engineers and experts who ensure to provide a cost efficient, commercially viable and GMP compliant design for each facility. More often than not, there is a long gap between completion of engineering work and start of operation. This phase needs skilled support and PharmSol experts provide this on a turnkey basis. PharmSol guarantees to reduce about 50% of the time taken by conventional system. •Facility Technical Assessment •Due Diligence •Conceptual Design Review  •Facility Design  •Facility Remediation •QMS (Multilingual)  •Qualifications & Validations

PharmSol Group Resources