At SPEK, we are your solution for all your submission and consultative needs in pharmaceutical, biological, natural health, and nutritional products.
SPEK Regulatory Consultants
Telephone: Sunita Phull @ (647) 234-4930
Ella Kos @ (416) 560-6637
Fax: (416) 223-9875
Launch of SPEK Regulatory Consultants
It is with much optimism that we, Sunita Phull and Ella Kos, announce the launch of a consulting partnership: SPEK Regulatory Consultants.
We are ex-Wyeth colleagues with over 40 years of Regulatory experience in several therapeutic areas throughout the regulatory lifecycle of a product, beginning from Phase I clinical studies to Market Registration and Post-NOC registration maintenance, and finally product discontinuation. Additionally, we have extensive regulatory experience in the registration and maintenance of infant formulas, and regulatory and labelling aspects of other foods.
SPEK's goal is to respond to your Company's needs, while at the same time meeting the Canadian regulatory requirements in the registration and maintenance of your pharmaceutical, and biological products, natural health products and nutritional products (e.g., infant formula).
The regulatory services we are offering are:
- Preparation of Clinical Trial Applications, Amendments, Notifications, ADR filings and liaising and coordinating GCP inspections;
- Working with the Client towards Pre-Submission Consultation meetings with Health Canada;
- Preparation of post approval CMC and labelling change applications;
- Establishment Licence Applications;
- Regulatory support during merger/acquisitions;
- Obtain CPPs in support of affiliate registrations;
- Preparation of Product License Applications for Natural Health Products;
- Preparation of Premarket Notification submissions for registration of Infant Formulas.
We will leverage our experience to meet your Company's needs in a timely and cost-effective manner. We look forward to the opportunity to discuss how we can be of service to you.