Medical Market Consultants
Managing the Business of Science™
“Spectrum MMC has served as Aplicare, Inc.’s Canadian regulatory affairs representative for over 17 years. The partnership has been symbiotic in that ensuring Aplicare’s business needs are supported by proactive regulatory support.
Over the years Spectrum MMC has carried out the following functions: GMP audit of Aplicare manufacturing facilities, preparation of regulatory submissions, support of Canadian customers, review of SOPs, review and maintenance of GMP documents, provided competitive intelligence as well as interpretation of Health Canada policies, guidelines and regulations while also dialoguing with the Regulator on behalf of the company. Their execution of these functions is performed efficiently and with attention to both regulatory compliance and business needs.
Aplicare views Spectrum MMC and its personnel as an invaluable business resource in which we have complete trust and confidence.”
Paul G. Buccetti
Regulatory Affairs Director
Experience. Service. Quality.
“Since we started to use Spectrum MMC’s services in November 2007, we have experienced that their actions, quality of the work, proper execution time and objective have been always fulfilled. Furthermore, in our particular case, we have to remark that we have also experienced exceptional efforts by Spectrum MMC to find out and overcome any barrier that could interfere in the achievement of our goals.
Therefore, we can only express our gratitude to Spectrum MMC for all their work done and pending to be done, as well as, to encourage them to continue this professional, committed and serious work that allows their customers to achieve their objectives.”
Guillermo Jiménez, Technical Manager
"Je peux témoigner sans hésitation de l’excellence des services rendus par l’entreprise et que le traitement qui nous a été réservé correspondait tout à fait aux attentes fixées en début de mandat."
"It can be very difficult for a small device and/or drug manufacturer to staff the proper personnel to keep up with the wide array of regulatory requirements on an international, national, or local level. For these requirements, the services of Spectrum Medical Market Consultants have been invaluable. Wayne Bryant conducts his business in such a manner that we often feel he is an extension of our direct staff. His knowledge, response time, and follow up is at a high level and we are very comfortable with his interpretation of regulations and advice."
Fran Carleton, General Manager
Dutch Ophthalmics, Inc.
"I have worked with Spectrum Medical Market Consultants and its founder Wayne Bryant for over 20 years and I continue to be impressed by the depth of knowledge and expertise the company offers in all areas related to the life sciences industry.
My initial introduction to Spectrum MMC was in accessing their marketing and advertising services to launch products for two multinational pharmaceutical companies. As our relationship evolved, Spectrum MMC has been called upon to provide support in: regulatory affairs, input on clinical issues, strategic planning, information services, competitive assessment and analysis, as well as counsel on how to interpret regulations related to drugs, medical devices and other product categories.
Spectrum MMC and its personnel are seasoned veterans who understand how to deliver results in the highly regulated and complex life sciences market.
Based on my experience, I could not be more pleased with Spectrum MMC and its obvious expertise and commitment to serving clients and their needs."
Life Sciences Industry
"We have been working with Spectrum MMC for over five years, and have always been satisfied with the professional approach, the quality of work and the value that your team has provided to our efforts, especially in our project to register SilverClear with the Health Canada's Medical Devices Directorate.
When a question comes up related to Canadian regulations or issues, we can always count on you and your team to guide us or put us in touch with the right contacts to get the information.
When we have issues with decisions taken by government officials, you are always in a position to guide us and support us in our decision to pursue the negotiations or move on."
Bernard A. Rose
Medifit Marketing Inc.
Je me réjouis de vous avoir référé à mes collègues de Shreis Scalene Sciences LLC du Maryland. Vous avez su vous joindre à des experts quant il a fallu éclaisir certains points avec les gens au Bangalore en Inde en égard aux normes de Santé Canada. J'ai grandement apprécié votre grande patience et je dois reconnaître que vous demeurerez toujours la personne au niveau professionnel pour qui j'ai un grand respect.
Cher Wayne, je te connais depuis au-delà de 30 ans et je sais qu'avec ton équipe je pourrai toujours compter sur Spectrum MMC concernant l'enregistrement de dossiers.
Shriéis-Scalene Sciences Inc.
As an outsourcing partner Spectrum Medical Market Consultants has provided valuable regulatory support in Canada to U.S. and international clients. They have provided services to me for many years and their work effort has always delivered the desired results.
The services ranged from managing a pan-Canadian clinical trial to the preparation and submission of multiple Clinical Trial Applications for various clients. For an innovative New Chemical Entity they provided CMC filling support for NDAs in the U.S. and the EU. The CMC work was carried out over several years that included dealing with commercial partners and numerous third party suppliers.
Spectrum MMC staff are very knowledgeable and are efficient and experienced in navigating the intricacies of government agencies that have oversight for the life science industry. In addition, while always maintaining their professionalism, the staff at Spectrum was always pleasant
Spectrum MMC continues to be the first company to which I would go for regulatory support in Canada.
Vice President, Regulatory
SIGA Technologies, Inc.
Spectrum played a very important role in setting the CMC regulatory stage for us to carry out our Phase 3 clinical trials in Canada and Europe, as well as reviewing /impacting our NDA & EMA submissions. Your high quality approach has made the journey to US NDA Approval a little less arduous and a little more fun. Thanks for everything!
Chief Operating Officer
U.S. Biotechnology Company