FAQ's for  DSA Consultants

Can DSA Consultants prepare my regulatory filings for Health Canada?

Can DSA Consultants act as my QC Department?

Can DSA help me to obtain a Drug Establishment License with Health Canada?

Is DSA Successful in obtaining Health Canada approval for Drug Establishment License (DEL) audits?

I just received an NC (Non-Compliant) rating during my Health Canada (HC) Inspection. Can you help?

My shipment was seized at the Canadian border. What do I do now?

How do you charge for your services?

Health Canada cited me for not having evidence to support storage and transportation conditions. I’m not sure what to do.

Can DSA Consultants guarantee a regulatory approval for a new drug submission or other project?

Can you provide me with some references or a list of your clients? I’d like to verify your qualifications before signing on as a client.


Can DSA Consultants prepare my regulatory filings for Health Canada?

Yes. DSA prepares a full range of regulatory submissions for drugs, medical devices, NHPs, and cosmetics. Our services range from review of submissions prepared by your staff to full preparation of the submission and management of the review process with Health Canada. Depending on the scope of your project, one or more DSA Regulatory Affairs Consultants who specialize in Health Canada Regulatory Filings will be assigned to your project.


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Can DSA Consultants act as my QC Department?

Yes. Our Senior Quality Consultants are all specialists in GMP compliance and GMP Consulting. They have at least 15 years of experience working in a drug GMP environment. Our QC and GMP Consultants have experience working in drug manufacturing, stability, analytical laboratories, and/or auditing. Based on your needs and the type of products that you manufacture or import, we assign a GMP or QC Consultant whose background and experience is the closest match to your needs.


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Can DSA help me to obtain a Drug Establishment License with Health Canada?

Absolutely. We believe in leveraging our skill sets internally and assign a Regulatory Constant to handle the registration aspect of the project and we assign a Quality Control/GMP Consultant to handle the compliance aspect of the project. We will prepare your SOPs (Standard Operating Procedures), review your GMP compliance documentation, ensure the compliance of your site, and manage the Health Canada Inspection on your behalf.


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Is DSA Successful in obtaining Health Canada approval for Drug Establishment License (DEL) audits?

We have a 100% success rate. No Client of DSA Consultants has ever received a non-compliance rating. We enjoy the challenge of working with a new client and helping them achieve GMP compliance and licensure by Health Canada.


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I just received an NC (Non-Compliant) rating during my Health Canada (HC) Inspection. Can you help?

We have worked with clients who find DSA Consultants after having received a NC (non-compliance) rating either while working on their own or with other consultants. Where this has happened, we have taken over dealings with the Health Products and Food Branch Inspectorate (HPFBI) and have always been successful in over-turning the NC rating into a Compliance rating.


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My shipment was seized at the Canadian border. What do I do now?

Call us immediately – we can help. We have worked with many clients who initiated their contact with DSA Consultants as a result of issues with Border Services, CCRA, customs or the Inspectorate. We work diligently on behalf of our clients to negotiate compliance measures and to help expedite release of their shipments. Depending on the issues, a DSA GMP Consultant or a DSA Regulatory Consultant can work with you on a short-term or on-going basis.


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How do you charge for your services?

We charge an hourly rate for the services that we provide. Generally, when project rates are charged there is a certain “buffer” built into the project rate to ensure that the consulting company is not underpaid for the work that they provide. We don’t feel this is a fair approach and do not feel comfortable charging you if we haven’t earned the income. With an hourly rate, you have the assurance that you only pay for the work that is performed and in turn we are compensated for the work that we provide. Our invoices provide a detailed account of how we charge for our time.


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Health Canada cited me for not having evidence to support storage and transportation conditions. I’m not sure what to do.

DSA Consultants can help. One of our Mapping & Validation Consultants can review your needs and recommend a solution for you. DSA offers a full range of services for temperature studies including freezer mapping and validation, cooler mapping & validation, incubator mapping & validation, warehouse mapping, packaging qualification studies, and shipping lane qualification including mapping and qualification of transportation vehicles. We offer a wide range of Mapping & Validation Consulting solutions to meet your needs.


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Can DSA Consultants guarantee a regulatory approval for a new drug submission or other project?

We like to use the analogy of comparing our services to that of a lawyer. If you are going to court, you can certainly try and defend yourself and you (potentially) could present a good case for yourself. By using a lawyer, you are hiring a specialist who has specific expertise to improve your case or your defence and can significantly increase your odds of winning a case. Just as a lawyer cannot guarantee a successful outcome to your case, we cannot guarantee a product approval. What we can do is use our skills and expertise to prepare the best possible submission that greatly increases your chances of approval. Because we prepare so many regulatory submissions each year, a DSA Regulatory Affairs Consultant has the ability to predict with greater certainty how the regulators will receive and review your submission. You benefit from the submission comments that we have received from other regulatory projects and we can address those submission deficiencies before your submission is even filed.


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Can you provide me with some references or a list of your clients? I’d like to verify your qualifications before signing on as a client.

We have agreements in place with some clients which legally prevent us from disclosing our relationship with them. Regardless, we protect the identify of our clients and our relationships with them. We extend this courtesy to all our clients and our potential clients. We’ve been in business for over 20 years and are very proud of our relationship within the industry. Although we cannot disclose the names of the companies we currently work with, we can disclose the names of the firms that our staff been employed by. Abbreviated biographies are posted on our website of our consulting team so you can see the background and expertise that our consultants bring to our team. We are happy to provide full curriculum vitae for any member of our team.


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