Supporting medical device companies throughout the product lifecycle

The medical device market is rapidly changing. New technologies are leading to ever tighter integration of drugs, devices and biologics, as well as software, electronics and physical products. New regulations are driving the industry towards new approaches for safety, device identification and clinical investigations, to name just a few areas. Increasing pressure on regulators is being passed on to manufacturers and importers. Recent FDA regulations around Combination Products and Unique Device Identification (UDI) and the upcoming finalization of the European Medical Device Regulations require companies to pro-actively manage their device and combination product portfolios to ensure operational efficiency and regulatory compliance.

At Navitas, we have a track record of successful medical device project delivery across many areas, including regulatory affairs, quality management, risk management, device vigilance and track & trace technologies. We offer deep industry insight, paired with project management experience, and work along the three dimensions of processes, people and technology. Our main offerings include, but are not limited to,

The Way We Work

We serve clients from the life science industry across multiple regions. We deliver services, technologies, and consultancy engagements to the medical device, biotech, and pharmaceutical sectors. We pride ourselves on our industry leading Networks, setting us apart from our competitors. We are happy to work in large or small teams, depending on the assignment and client requirements. We focus on customer needs and measure both progress and success. Our staff are expert navigators, fulfilling the role of project manager as well as being subject matter experts, delivering value from day one.

Latest News

24
Jan2017

Navitas Networks announce Forum dates for Spring, 2017

The Navitas Networks are pleased to confirm the dates for our upcoming Spring forums... ...

17
Jan2017

Navitas Launches Labeling Assessment Express

Regulators are changing the way they look at labeling. The emphasis is on ensuring...

02
Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures...

05
Oct2016

Navitas at DIA's 10th Annual Forum for Qualified Persons...

Navitas Principal Jeffrey Ho will present "Efficient content management for the compilation and...

04
Oct2016

News 2016

[row id="1" class="ROW_CLASS"] [col class="span12"] 02 Nov 2016 AbbVie and Navitas Present Case Study on the Evolution...

27
Sep2016

Navitas releases paper on CDISC, the standards and why the...

The FDA (and eventually, regulatory agencies from around the world) will require clinical data...

13
Sep2016

AbbVie and Navitas Present Case Study on the Evolution and...

At 10:30a.m. (East Coast Time) on September 22nd, Navitas and AbbVie will...

29
Jul2016

Navitas Networks announce Forum dates for Autumn, 2016

The Navitas Networks are pleased to confirm the dates for our upcoming Autumn forums....

12
Jul2016

Navitas Celebrates 100th pharmaREADY customer

pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite...

28
Jun2016

Navitas' PVTech Summit Defines Future Success

Navitas’ PVTech Summit was held on June 15th at the Hudson Hotel in New...

18
May2016

Navitas Welcomes Tara Baer to Navitas

Navitas is pleased to welcome Tara Baer, who joins Navitas' Regulatory Practice. With over...

18
May2016

Navitas Speaks at Sparta Connection in Orlando

David Gwyn, Navitas' Technology Practice lead, will unveil idmpREADY at the Sparta Connection conference...

14
Mar2016

Navitas Earns Speaking Sessions at DIA’s 52nd Annual Meeting

In two different sessions, Subject Matter Experts from Navitas will address new challenges facing...

09
Mar2016

Navitas is pleased to announce the introduction of our networks...

Navitas' inaugural pvindia meeting took place in Mumbai on Thursday 03 March, 2016. ...

25
Jan2016

Navitas Announces the Inaugural pvindia Forum

Navitas will soon be adding to our portfolio of industry leading networks with the...

18
Jan2016

Navitas Relaunches pharmaREADY.com

pharmaREADY.com is Navitas' next generation website for its fully integrated, regulatory compliant document management,...

14
Dec2015

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and...

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and Future of the Pharmaceutical...

03
Nov2015

The changing trends in drivers of life sciences R D...

Outsourcing is not new in the life sciences sector. Clinical research outsourcing, contract sales...

05
Oct2015

Navitas Announces Inaugural Clinical Data Strategy Network cdsnet

Navitas is excited to announce a new edition to their industry leading networks portfolio...

10
Sep2015

Navitas Introduces Innovative Regulatory Process Outsourcing Model

The workload for regulatory functions of pharmaceutical companies has continued to increase in recent...