SPharm’s
services:
Regulatory:
- Strategic planning in
product
development;
- Preparation/rehearsal
of pre-submission meetings with Health Authorities;
- Preparation of Appeal
dossiers and rehearsal of related meetings with Health
Authorities;
- Evaluation of
preclinical, clinical and chemistry data for approval by Health
Authorities;
- Preparation of
regulatory submissions:
Clinical Trial Application (CTA), New Drug Submission (NDS),
Supplemental NDS, Abbreviated NDS, Notifiable Change (NC), all
prepared in the CTD format;
- Follow up on
regulatory dossiers throughout the approval process;
- Liaison with Health
Authorities;
- Annual Drug
Notifications;
- Writing/revision of
Product Monographs (including revision for new Canadian
format);
- Review of labelling
and advertisement material;
- Basic training
sessions on various aspects of product development for a better
application of the regulations and set up of regulatory affairs
processes;
- Scientific literature
reviews;
- General regulatory
advice.
Compliance:
- Set up/audit of the
quality program of importers/distributors in Canada according to
current Good Manufacturing Practices (cGMP);
- Writing and revision
of Standard Operating Procedures (SOPs) for importers/distributors
in Canada;
- Preparation/renewal of
Establishment license;
- Preparation/Renewal of
controlled substances license and permits.
Services available
through alliances:
Working in partnership with
Contract Research Organizations (CROs), laboratories and other
selected high quality and efficient allies, SPharm is able to offer
clients a wide range of related services that include:
To find
out more about the quality and scope of services we offer in both
English and French, please contact today Susanne Picard, President, Tel.:
(819) 824-6869.
