Clinical Drug Development

We plan clinical drug development, including strategies for obtaining regulatory approval with optimal labeling and Phase I-IV study design aimed at streamlined development for fastest time-to-market.

We prepare clinical protocols that will support regulatory approval of the product and optimal product labeling. Our offerings include protocol preparation and implementation in compliance with regulatory requirements and international standards such as ICH and GCP, Case Report Form design, Investigator Brochure preparation, site selection and investigator recruitment for clinical trials, management of clinical trials and post-market product line extension studies.

Regulatory Affairs

Our pre-CTA/IND support includes advising on Health Canada and FDA requirements, reviewing non-clinical product data to ensure these data support the clinical drug development plan and lead to a successful filing with regulatory authorities, providing guidance on interactions and meetings with regulatory authorities and advising clients on pharmacology and toxicology requirements.

We support CTA/INDs by reviewing/evaluating non-clinical data, assisting in clinical trial design and organization, preparing clients for pre-CTA/IND meetings, and preparing or reviewing CTA/IND submissions. We also prepare CTA/IND amendments and can assist in preparing annual reports.

For NDS/BLAs, we evaluate the clinical data prior to filing and we help prepare the submission (including CTD format). In addition, we provide facility inspections and C&M data review in collaboration with our affiliates. We act as regulatory agents for overseas clients filing New Drug Submissions in Canada.

Our post-market support includes preparing safety updates for regulatory authorities and advising on product line extension studies.

We assist our clients in addressing any issues raised by regulatory authorities.

We provide regulatory services for the USA in collaboration with our partner FDA consultants stateside.

Training & Seminars

We provide training and seminars on the following topics: clinical drug development, the biologics approval process in Canada and the US, biologics and their regulation, biologics C&M and quality control (Canada and US), post approval requirements and the Periodic Safety Update Report, guidance documents and ICH guidelines including Good Clinical Practices, and clinical study documents-regulatory requirements.

Due Diligence

We provide due diligence services for investors, government, and investigators. This service includes reviewing clinical and scientific data and advising on regulatory and feasibility issues.

We review clients’ overall drug development strategy and individual project plans to ensure that the hypotheses and studies support optimal drug labeling, and that planned studies are compliant with regulatory requirements. We also review proposed NDS data or entire NDS/BLAs prior to submission to regulatory authorities.

Novel products

We work with clients and regulatory authorities to develop regulatory requirements for safety and efficacy of novel products for which no standards or regulatory precedence exist.

Agents

We can serve as the North American agent for international organizations and as the Canadian agent for US or international organizations.