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Regulatory Services
PDi-Regulatory Services, a Division of PDi-Pharmaceuticals,
Inc. provides contract consulting to the pharmaceutical industry. A team
of associates has been assembled with expertise in most aspects of pharmaceutical
development, from concept to reality.
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We have practical working experience with drugs in most major therapeutic areas with an emphasis on Parenteral Drugs. |
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PDi offers solid experience and background working in the Canadian market place. |
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Utilizing our close network of outside Consultants and Experts we can also provide regulatory and scientific support
for pre-clinical and clinical development including protocol design, clinical trial project management, and integrated study report writing. |
PDi-Regulatory Services is committed to providing its clients with quality regulatory services, personalized attention, logical and practical, common-sense, guidance.
Our goal is to build long-term working relationships based on trust and mutual respect allowing us to serve you effectively and accelerate your products’ time-to-approval.
Regulatory Services – Overview:
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Approval Strategies -
PDi has extensive experience with Health Canada - our Regulatory Body.
We offer a globally focussed approach
to all our clients, which in many
cases, has resulted in expedited approvals. |
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Agency Representation -
PDi can provide coordination, preparation and participation in agency meetings at all stages of drug development.
We offer experience in most therapeutic areas, a reputation of honesty and integrity with the agency review divisions,
and a practical, logic common sense approach towards agency cooperation and partnership. |
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Preclinical and Clinical Development -
Through a network of collaborative and strategic alliances, if required, PDi can assist in the development of
customized preclinical and clinical development plans and coordinate the execution of those plans in accordance
with GCPs, ICH, and local regulations. We can assist in assembling a product-specific team of experts to ensure
your product development proceeds in a timely and strategic manner. |
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Submission Preparation -
ANDS, DMF, PMA, priority review requests,
orphan drug applications, annual reports, safety reports, and amendments
can all be perused, compiled and submitted. We offer practical and
proven experience in preparing Canadian submissions in accordance
with the new CTD guidances. PDi offers you a proven track record of
product approvals. |
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Electronic Submissions -
We have experience in preparing electronic submissions in Canada. Keeping abreast of the developments worldwide
towards electronic pharmaceutical documentation is a prime focus. All your regulatory documentation can be prepared
and archived in paper or electronic formats. |
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Sales and Marketing Aids/Label Review -
We can assist in developing or reviewing advertising materials and product labelling from a regulatory compliance perspective. |
Contact by eMail:
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