Quality & Regulatory

Pharmaceutical Quality Assurance & Regulatory Consultants

Pharmaceutical Quality and Regulatory Consulting Services

Given the myriad and complex tangle of government bodies and agencies that span the multiple areas in which medical device and pharma/biotech companies operate, achieving and maintaining compliance with relevant regulations can be challenging. Our complete range of medical device and pharmaceutical quality and regulatory consulting services ensures that your company remains on the straight and narrow no matter how complicated your obligations may be.

GForce Life Sciences offers a full range of quality and regulatory support, from initial strategy and submissions to meeting and working with the FDA. We provide expert insight, help extend the reach of your in-house quality or regulatory team, or handle everything as your quality or regulatory department. Our qualified experts provide consulting advice from the early phases of pharmaceutical development through marketing applications and post-market activities.

Whether you need help with pharmaceutical regulatory affairs management or assistance with quality assurance in the biotech industry or medical device sector, the expertise and industry-specific focus we bring to the table mean we have what it takes to provide the consulting capabilities you need.

Quality Assurance Services

  • Manufacturing Oversight (GMP)
  • Deviation and CAPA
  • Management
  • Process Design, Harmonization and Validation
  • Quality Assurance/Quality Compliance
  • Remediation Services
  • Verification and Validation
  • Post-Market (Complaints, Adverse Events, Recalls)
  • QA SOP Development
  • Site and Vendor Qualification and Auditing (GMP, GCP, GLP, CLIA Accreditation)
  • Internal Sponsor/Due Diligence
  • SOP Audits
  • Supplier/Distributor Audits
  • Mock FDA Audits
  • Inspection Readiness

Regulatory Capabilities and Services

  • Manage regulatory affairs
  • Prepare or review dossier/submission and file
  • Oversee pre-meeting packages, INDs/CTAs and post-filing submissions
  • Submit BLA/NDA/NDS/MAA filings (U.S., Canada, EU)
  • Prepare regulatory submissions for other worldwide agencies in Europe, Middle East, South America, Australia and Asia
  • Develop regulatory strategy for the product’s life cycle
  • Consider international regulatory requirements
  • Meet international filings
  • Revise plans as guidelines change
  • Facilitate interactions with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and toxicology matters
  • Liaison with regulatory agencies on Regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
  • Respond to regulatory agency questions
  • Oversee regulatory classification of products across different jurisdictions
  • Provide expert regulatory CMC compliance advice throughout development
  • Work with sponsors and regulatory authorities through the resolution of complex development issues
  • Act as U.S. Representative for U.S. submissions, as EU Agent in Europe and as Canadian Representative for Canadian submissions
  • Assist with due diligence activities for investors/licensees
  • Offer scientific and medical writing services
  • Offer regulatory electronic submission publishing services (eCTD)
  • Support company post-market (complaints, adverse effects, recalls)

“I was extremely impressed with the high level of professionalism that the team brought to our site. They integrated quickly and became a part of our company mission. What impressed me most was seeing how the GForce team responded to the high expectations set during remediation efforts and how they exceeded them.”

— GForce Client

Learn how GForce Life Sciences can help accelerate your growth.

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