Product Development

The Pharmaceutical & Healthcare Group can help companies develop strategies for product development. Working closely with our clients, our oversight and assistance covers lead candidate selection to final regulatory submissions and post-market activities.

Our global perspective and scientific expertise will ensure that you begin the journey toward long-term success. Our flexibility and team approach will ensure that the collaborative process with Ashuren will bring efficiency and manageability to your development program.

• Comprehensive product development strategies meeting international standards, focusing on regulatory and toxicology requirements:
  • Nonclinical studies required for next phase of Clinical Development;
  • Management of CMC issues such has formulation changes, etc.;
  • Timing and requirements for regulatory submissions to support ongoing development activities.
• Preparation, review, management and filing of submissions worldwide in CTD/eCTD format:
  • Pre-INDs, INDs, CTAs, BLA, NDAs, NDSs, MAAs, 510(k)s, PMAs, IMPDs, Pre-Submission Briefing documents, Investigator’s Brochures, Annual Reports, Integrated Summaries, etc.
• Scientific writing of nonclinical data (safety), clinical data, and preparation of CMC documents:
  • Manage the nonclinical program, Quality (CMC) component, facilitate clinical program to support registrations worldwide.

Intertek Cantox helps companies coordinate nonclinical, clinical, and manufacturing efforts to reach company milestones and objectives. The regulatory affairs and toxicology teams at Cantox have experience in the following Therapeutic/Product areas:

• Therapeutic Areas:
  • Anti-HIV
  • Anti-Infectives
  • Anti-Inflammatory
  • Anti-Viral
  • CNS
  • Diabetes
  • Gastrointestinal
  • Asthma/COPD
  • Autoimmune
  • Cardiovascular
  • Hepatitis
  • Oncology
  • Pain
  • Psoriasis
• Compound Classes:
  • Antibiotics
  • Antisense molecules
  • Growth Factors
  • Monoclonal antibodies
  • Peptides
  • Protease inhibitors
  • Recombinant proteins
  • Small molecules
  • Thrombolytics
  • Vaccines
• Product Types:
  • NCEs
  • 505(b)(2) Applications, Generics
  • Pharmaceuticals
  • Biotechnologicals
  • Biologics (Blood/blood products, rDNA products, etc.)
  • Natural health products (NHPs)
  • Medical Devices
  • Combination products
  • Radiopharmaceuticals
  • Cosmetics and personal care products
  • Veterinary products