USFDA Guidance

USFDA Guidance
Product Description

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

Read more Show less

PharmSol Group

  • MT
  • 2015
    On CPHI since
Company types
Consultancy
View company profile
Categories
more categories Show less
Sales Markets
Show more Show less

PharmSol Group

  • MT
  • 2015
    On CPHI since
Company types
Consultancy
View company profile

More Products from PharmSol Group (4)

  • 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 Au...
  • 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 turnke...
  • 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&nb...
  • 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&nb...

PharmSol Group resources (1)