Product Consulting

Regulatory Consulting

GCR’s strategic regulatory consulting team is comprised of seasoned pharmaceutical industry senior regulatory experts with extensive multi-regional experience in product development and strategic planning, execution and achievement of successful product registration with regulatory authorities worldwide.

Our team develops and manages product- and indication-specific regulatory strategies that enable the most efficient registration pathway(s) and yield a high probability of approval success. Our consultants draw upon GCR’s internal regulatory affairs knowledge and expertise in preclinical; chemistry, manufacturing and controls (CMC); and clinical and commercial development to build strategies that meet the demands of a dynamic regulatory environment.

We offer a complete spectrum of comprehensive regulatory consulting services including:

  • Strategic consulting and intelligence
  • Negotiate/Interact with regulators
  • Marketing application preparation
  • Clinical trial applications
  • Medical devices
  • Lifecycle management
  • Preclinical and CMC consulting
Regulatory Consulting

Therapeutic Area Consulting

Our product development consulting team brings the expertise and experience you need to continue to successfully deliver these therapies to the market:

  • Therapeutic area expertise in a wide variety of diseases and indications including haematology / oncology, cardiovascular disease and critical care, neuroscience, infectious diseases, metabolic disease, rheumatology, ophthalmology, respiratory and general medicine, including extensive expertise in the development of pharmaceutical products in rare diseases and paediatric indications
  • Experience in the development and approval of medical devices and companion diagnostics
  • Full range of biostatistical consulting to support first-in-human through post-approval studies
  • Effective team leadership that synchronises cross-functional services, global development expertise and insight from therapeutic thought leaders and physicians to create customised integrated development strategies

Chemistry, Manufacturing and Controls (CMC)

Expertise in All Areas of CMC Development

Our CMC team has experience with a variety of compound types (small molecules and biologics, including biosimilars), dosage forms, routes of administration and therapeutic areas. Our highly trained staff has advanced degrees in a variety of scientific disciplines, such as chemistry, biochemistry and pharmacy, and work experience in large pharmaceutical organisations, as well as in virtual and start-up biotech operations.

Product Development and Regulatory Strategies

  • Fast-to-clinic and first-in-man strategies to minimise drug use via compounding in clinic
  • Regulatory documentation and due diligence reviews prior to compound purchase
  • CMC regulatory strategies and advice from lab bench to pharmacy shelves
  • Formulation, analytical and manufacturing process development advice on formulations and drug delivery approaches
labs and early development

Pharmacology / Toxicology

Pharmacology/toxicology consultants design and implement comprehensive nonclinical plans to enable successful product development from early discovery through post-approval lifecycle management. GCR’s nonclinical team has experience with a variety of compound types (small molecules and biologics, including biosimilars), targets, routes of administration and therapeutic areas.

Our nonclinical development experts work with clients to:

  • Design streamlined, efficient pharmacology/toxicology programs to support the intended dose, route and duration of treatment in the clinic and enable successful regulatory filings
  • Identify and address key pharmacology and toxicology issues unique to the compound, the indication or the patient population, in accordance with relevant regulatory guidances
  • Provide advice on budgets, timelines and global regulatory requirements
  • Design nonclinical studies, prepare protocols, monitor studies, and review data and reports
  • Provide literature-based toxicological assessments of extractable/leachable studies and devise strategies to support manufacturing changes and to identify/qualify impurities and degradation products
  • Prepare and review nonclinical summaries for global regulatory submissions, including but not limited to IND/CTA and NDA/BLA/MAA and meeting packages
  • Provide expert toxicology representation before regulatory authorities
  • Develop gap analysis of nonclinical packages with assessments of strengths, weaknesses, opportunities and threats
  • Support business development activities by leading nonclinical tasks for due diligence activities, preparing and reviewing nonclinical packages for partnering/out-licensing efforts, and representing companies sharing global programs and strategies to potential partners/outside investors
Pharmacology Toxicology consulting