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Pharmaceuticals, Biologics and Biotech

Drug includes any substance or mixture of substances manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,

(b) restoring, correcting or modifying organic functions in human beings or animals, or

(c) disinfection in premises in which food is manufactured, prepared or kept;

Pharmaceutical Regulations:

Pharmaceuticals are regulated in the U.S. by the FDA’s Center for Drug Evaluation and Research (CDER) and in Canada by Health Canada’s Therapeutic Products Directorate (TPD). In order to sell a pharmaceutical product, a manufacturer must obtain regulatory approval for a New Drug Application (CDER) or a New Drug Submission (TPD).

Biologics/Biotech Regulations:

Biologics and biotech products are regulated in the U.S. by the FDA’s Center for Biologics Evaluation and Research (CBER) and in Canada by Health Canada’s Biologics and Genetic Therapies Directorate (BGTD). In order to sell a biologic or biotech product, a manufacturer must obtain regulatory approval for a New Drug Application (CDER) or a New Drug Submission (TPD).

Services Offered:

Regulatory Affairs:

Canada:

(a) Preparation of New Drug Submissions

(b) Preparation of Abbreviated New Drug Submissions

(c) Preparation of Supplemental New Drug Submissions

(d) Preparation of Clinical Trial Applications

(e) Preparation of DIN Application

(f) Preparation of Drug Establishment License Applications

(g) Preparation of Drug Master Files

(h) Preparation of Site Reference Files

(i) Follow-up and Support with Health Canada

(j) Product Monograph Preparation

(k) Package Labeling- Preparation and Review

U.S.A.:

(a) Preparation of Investigational New Drug Applications

(b) Preparation of New Drug Applications

(c) Follow-up and support with F.D.A.

Good Manufacturing Practices:

(a) Develop and maintain compliance with Good Manufacturing Practices (GMP)

(b) GMP Training

Good Laboratory Practices:

(a) Compliance with Good Laboratory Practices

Products Licensed/Clinical Trial authorizations:

(a) Narcoleptics

(b) Anti-convulsant drugs

(c) Oncology therapies (biological response modifiers, monoclonal antibodies, monoclonal antibody fragments)

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