Why the synergy between biotech companies and PLG makes sense

Discovering and developing breakthrough new medical treatments that alleviate suffering, extend life, and improve quality of life require time, great people, significant resources, collaboration across sectors and geographic borders, and complex and risky processes—with no guarantee of success.

From conception and development to approval and launch, each stage of the commercialization process requires individuals with various kinds of specific expertise in areas ranging from clinical data collection to capturing and reporting adverse events. Today’s ever-changing laws and regulations have led to a growing demand for professionals who understand the overall regulatory landscape and can help companies effectively bring products to market. Developing that understanding requires staying up-to-date on emerging trends within the industry.

PLG has assembled a team of biopharmaceutical regulatory experts who have extensive experience in and deep understanding of the areas of biopharmaceutical product development, registration, market access, health economics, and commercialization.

PLG provides flexible and tailored, preclinical, clinical, and market access solutions designed to help small and midsize biopharmaceutical companies move forward in their efforts to get treatments to patients—from helping define a development plan to assisting with the implementation of all stages of product development and through launch and commercialization—in order to deliver compelling results to regulatory authorities, investors, and stakeholders.

PLG assists companies in reaching their product development milestones faster and in effectively managing their development programs from preclinical to postmarketing stages.

Read more about our flexible and tailored, early-stage, preclinical, clinical, and market access solutions.

Strategy consulting service

Short description: Strategy ranges from conducting market studies to the proposing of a go-to-market approach and proposing of the right business tools and solutions to support the strategy.

Deliverables include:

  • Assessment of performance benchmarks of eligible indications
  • Recommendations for first indications to pursue
  • Clinical studies implementation strategy
  • European market strategy and prioritization
  • Business case proposal
  • Go-to-market approach

Regulatory affairs support

Regulatory affairs (RA) support aims to define the best way for a biotech company to develop, register, and maintain its product on the market. That includes implementing a regulatory strategy for fast-track access to market.

Deliverables:

  • Gap analysis report
  • Consulting and advice, including RA strategy and development
  • Operational support: Prepostmarketing-authorization activities, clinical operations, and interactions with health authorities
  • RA operations such as clinical trial application, operational due diligence, scientific advice, pediatric investigation plan (PIP), presubmission meeting, and good manufacturing practice (GMP) clearance
  • Regulatory intelligence (local requirements)
  • Registration dossier and publishing
  • RA planning and execution follow-up

Pharmaceutical development, CMC, and quality

From early-stage development and at every point through to commercialization, PLG ensures that robust manufacturing and operational processes get properly documented to meet regulatory authorities’ requirements.

Our teams support development of the chemistry, manufacturing, and control (CMC) process to ensure that quality manufacturing standards have been established.

PLG assists companies in reaching their product development milestones faster and in effectively managing their development programs from preclinical to postmarketing stages.

Short description: Pharmaceutical development, CMC, and quality service help establish the best way for a biotech to develop, register, and maintain its product on the market.

 

Deliverables:

  • Gap analysis report with action plan
  • Support to improve operational efficiencies
  • Pharmaceutical development report review (formulation, analytics, scale-up)
  • Streamlining of development processes
  • Pre–Investigational New Drug Application (IND), IND application, clinical trial authorization application (CTA), New Drug Application (NDA)
  • Pharmaceutical variations
  • Quality management system
  • Good-practice audits of partners

Learn more about our end-to-end regulatory affairs, CMC, and Quality Center of Excellence

Clinical trials

Clinical trial design for biopharmaceuticals is complex, requiring access to specific patient populations and a sharper focus on safety in order to clear regulatory hurdles. PLG assists start-up and midsize companies in integrating tailored clinical solutions for clinical trials from phase 1 through phase 3.

 

Deliverables:

  • Statistics expertise
  • Biostatistics expertise
  • Development of an entire clinical plan
  • Clinical monitoring
  • Regulatory expertise
  • Project leadership
  • Investigation brochures
  • Toxicology expertise
  • Clinical study report writing and review
  • Product information in the forms of company core data sheet (CCDS), summary of product characteristics (SmPC), and medical information materials

Market Access

Short description: PLG’s market access support helps companies (1) understand pricing and reimbursement conditions within individual countries and (2) define the best market access strategy within a rapidly changing global landscape.

 

Deliverables:

  • Market study
  • Marketing road map
  • Promotional action plan
  • Sales forecast
  • Key opinion leader (KOL) identification per country and per drug category
  • Communication plan
  • Targeted hospitals
  • Partner identification and selection

The ability of biopharmaceutical products to address previously untreatable diseases is leading to unprecedented acceptance of innovative treatments.

Ahmed Bouzidi

Vice President, Biotech Strategic Development

Ahmed Bouzidi

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