Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Pyxa Solutions Overview

2,119 views

Published on

Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.

Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.

Published in: Health & Medicine
  • Be the first to comment

Pyxa Solutions Overview

  1. 1. Pyxa  Solu*ons,  LLC   COMPANY  OVERVIEW  
  2. 2. A  BOUTIQUE  PROFESSIONAL  SERVICES   COMPANY  FOCUSED  ON  R&D  DELIVERY     WITH A SPECIALTY IN CROSS-FUNCTIONAL R&D SERVICES AND SOLUTIONS FOR THE PHARMACEUTICAL, BIOTECH AND MEDICAL DEVICE INDUSTRIES
  3. 3. 3   FOUNDATION   9/24/16   TRANSFORM.  INNOVATE.  DELIVER.   PYXA  WAS  FOUNDED  IN  2012,  WITH  HEADQUARTERS   IN  THE  GREATER  PHILADELPHIA  AREA  
  4. 4. 4   OVERVIEW   Pyxa  SoluDons  is   comprised  of  a  dynamic   team  of  management   consultants  and  R&D   subject  maTer  experts   specializing  in  cross-­‐ funcDonal  R&D  delivery   stemming  from  acDviDes   led  by  Regulatory  Affairs     9/24/16   Delivering  over  100+   engagements  In  over  40   companies,  Pyxa  offers   robust  professional   services  in  strategic  and   operaDonal  business  and   technology  soluDons  for   the  PharmaceuDcal,   Biotech  and  Medical   Device  industries       Our  operaDonal,   strategic,  consulDng  and   technology  services  span   across  R&D  with  a  focus   on  all  regulatory   specialDes  within  and   across  the  enDre  product   lifecycle,  for  both  major   and  emerging  markets     R&D  DELIVERY  WITH  A  SPECIALTY  IN  CROSS-­‐FUNCTIONAL  SERVICES    
  5. 5. 5   DRIVING  VALUE   9/24/16   We  provide  regulatory   systems  and  project   management  exper*se  to   enable  organiza*ons  to   deliver  on  their  goals  and   jus*fy  investment  in  end-­‐ to-­‐end  regulatory   informa*on  management   by  increasing  strategic   delivery  while  reducing   commodity  tasks   We  ac*vely  help   organiza*ons  improve   their  R&D  performance   through  organiza*onal   analysis,   recommenda*ons,   development  of   improvement  plans  and   implementa*on  of  robust   solu*ons  that  are  scalable   and  adaptable  to  the   changing  regulatory   environment   We  evaluate   organiza*ons  holis*cally,   across  all  of  the   departments  involved  in   inpuVng  or  consuming   regulatory  data  to  achieve   significant  and   measurable   improvements  in  cost,   quality,  compliance  and   *me-­‐to-­‐market.  
  6. 6. 9/24/16   6   PRACTICE  AREAS   OPERATIONS   STRATEGY   CONSULTING   TECHNOLOGY  
  7. 7. 9/24/16   7   PRACTICE  AREAS   STRATEGY  R&D  STRATEGIC  SERVICES   Product  Development  &   Planning     Global  Labeling  &   Regulatory  Strategy   Technical  PM  (e.g.   Labeling,  Submissions)   Data  /  Informa*on   Governance  &  Strategy   Risk  Management  and   Compliance     Informa*on   Management  
  8. 8. 9/24/16   8   STRATEGIC  SERVICES   Product  Development   &  Planning     Pre-­‐IND/CTA   Leading  Global  R&D   Product  Strategy       Global  Dossier   Strategy   Core  submission  package   Simultaneous  &  strategic   global  filings   Post-­‐Marke*ng   IND/CTA  &     Marke*ng  Applica*on   Drug  Product/Substance   InformaDon  Maintenance   post-­‐submission   Briefing  Document   ScienDfic  Advice     Global  Filing     Strategies   IteraDons   New  indicaDons   Label  updates   CMC  changes   New  markets   RegistraDon     Management   PromoDonal   materials   management   IB,  Protocol,  CSRs  &  Clinical   Summaries     Pre-­‐clinical  Reports  and   Summaries     Acquisi*on  
  9. 9. 9/24/16   9   STRATEGIC  SERVICES   Global  Labeling  &   Regulatory  Strategy   One  Stop  Shop  for   all  Global  Labeling   and  Regulatory   Strategy  Services   Efficient  Global     Labeling  Process  that   enables  monitoring,   tracking  and  repor*ng   of  labels  from  crea*on   of  the  Company  Core   Data  Sheet  through  to   implementa*on  to  Local   Labels  and  finally  hand-­‐ off  for  Artwork.     Labeling  Opera*ons   Structured  Product     Labeling  (SPL)     Management  of  Drug   LisDngs     Data  and  Document   MigraDon  /  Management   System  Requirements     Labeling  Strategy   Full  outsource  global   labeling  support  for  Label   Management     Drug  Development  and   Post-­‐markeDng  Labeling   Strategy   Compliance   Metrics,  Tracking,     ReporDng,  Standards,   Templates,  Global   RegulaDons  /  Policies   Organiza*on   Governance,  Process,   Training,  FTE  Analysis,     OrganizaDon  Structure,   Design  and  OpDmizaDon   New  Legisla*on       eXtended  EudraVigilance   Medicinal  Product   DicDonary  (XEVMPD)       IdenDficaDon  of     Medicinal  Products     (IDMP)  
  10. 10. 9/24/16   10   STRATEGIC  SERVICES   Technical  PM  (e.g.   Labeling,  Submissions)   Pyxa  provides   technical  project   and  program   management  to   ensure  accurate  and   quality  deliverables   Providing  Technical   Project    Management   Support  on  a  variety  of   cross-­‐func*onal  R&D     Ini*a*ves   Product  strategy   Label  Alignment   System   implementa*on   Standards  Process   Best     Prac*ce   Gap     Analysis  
  11. 11. 9/24/16   11   STRATEGIC  SERVICES   Risk  Management  and   Compliance   Developing,   policies  or  SOPs   within  a  func*on   or  cross-­‐ func*onally     Communica*ng,   Implemen*ng   and  training   func*ons  on   new     Regula*ons   Founda*onal   Risk   Management   Assessments   Developing  and   implemen*ng   compliance  and   value  tracking   and  repor*ng   Pyxa’s  broad  and   diverse  range  of   services  enhance   compliance  and  aid   in  risk  management   and  mi*ga*on     Closed-­‐loop     between  change   control  and  regulatory   submissions    
  12. 12. 9/24/16   12   STRATEGIC  SERVICES   Data  /  Informa*on   Governance  &  Strategy   Leverage  data   to  improve   processes   Transi*on  from   data  to   ac*onable   insights   Create   dynamic  data   models  that   are  easy  to   sustain   Increase   compliance   through   visibility  into   tangible     metrics   Improve   regulatory   intelligence   through   learning  and   data  sharing   Turn  sta*c   data  into   ac*onable   triggers     Reduce  costs     by  elimina*ng   data  redundancy,   commodity  tasks   &  varia*ons   Compliance   with  increased   data  repor*ng   requirements   Registra*on,   submission,   correspondence   &  commitment   tracking   Cross-­‐func*onal   data  /   informa*on   governance  and   management  
  13. 13. 9/24/16   13   STRATEGIC  SERVICES   Informa*on   Management   Business   process-­‐based   applica*on   RIM  Strategy  &   Implementa*on   Challenge  IT   complexity   Data   simplifica*on   Connect   informa*on   flows   Shared   services  for   rou*ne   ac*vi*es   Mul*-­‐ func*onal   Approach   A  unique   holis*c  view  of   processes,   data  and   requirements     A  deep   understanding  of   the  informa*on   flows  between   Regulatory  Affairs   and  other   func*onal  areas     EVMPD eCTD IDMP
  14. 14. 9/24/16   14   PRACTICE  AREAS   OPERATIONS   R&D  OPERATIONAL  SERVICES   Submission   Management   Document   Management   Publishing   Document  /  Data   Migra*on   Informa*on   Management  Systems  
  15. 15. SUBMISSION-­‐READY  DOCUMENT  PREPARATION     Ensure  compliance  with  appropriate  ICH,  eCTD,   paper,  and  regional  guidance's   PROJECT  MANAGEMENT  FOR  GLOBAL  SUBMISSIONS   Manage  R&D  Submission  Team  and  Submission  for   all  major  and  minor  submissions     9/24/16   15   OPERATIONAL  SERVICES   SUCCESSFUL   MANAGEMENT  /   DELIVERY  OF   GLOBAL    LIFECYCLE   SUBMISSIONS  GLOBAL  SUBMISSION  GUIDANCE  INTERPRETATION   AND  DOCUMENT  AUTHORING  SUPPORT   Paper,  eCTD  and  NeeS  submission  compilaDon,   publishing  and  delivery   Submission   Management   PROVIDE  GUIDANCE  /  MANAGE  OUTSOURCING  OF   STRUCTURED  PRODUCT  LABELING  (SPL)   Content  of  Labeling,  Drug  LisDngs,  Establishment   RegistraDons  
  16. 16. 9/24/16   16   OPERATIONAL  SERVICES   Publishing   SUCCESSFUL   LEADERSHIP/ PUBLISHING  OF   GLOBAL   SUBMISSIONS     DOCUMENT  QC  AND  READINESS   CROSS-­‐REFERENCING  AND  HYPERLINKING   STRATEGIES   CTD  GRANULARITY  GUIDANCE   ICH  AND  GLOBAL  DATA  STANDARDS   PAPER,  ELECTRONIC  AND  ECTD  AND  NEES  
  17. 17. 9/24/16   17   OPERATIONAL  SERVICES   Document   Management     STRATEGIC  DOCUMENT  MANAGEMENT  FOR     ACQUISITIONS,  MERGERS,  DIVESTMENTS  AND   LITIGATIONS   DOCUMENT  STORAGE  STRUCTURES  AND  SUPPORT   (ARCHIVING  AND  DICTIONARY  MANAGEMENT)   NAMING  STANDARDS  AND  PLACEMENT  RULES   PROVIDE  ASSESSMENT  OF  TECHNOLOGY  SOLUTIONS  FOR   OPTIMAL  DOCUMENT  MANAGEMENT   LEGACY  DOCUMENT  MANAGEMENT,  (E.G.  GAP  ANALYSIS,   MIGRATION,  FORMATTING)  
  18. 18. 9/24/16   18   OPERATIONAL  SERVICES   Document  /  Data   Migra*on   DATA  CLASSIFICATION   REGISTRATION  DATA   STANDARDS  AND  TEMPLATES   PROCESS  AND  TRAINING   CONCEPTUAL  DATA  MODELS  
  19. 19. 9/24/16   19   OPERATIONAL  SERVICES   Informa*on   Management  Systems   CONTENT  MANAGEMENT  SYSTEMS         Veeva  (Vault)   Documentum  (EMC2)   FirstDoc  (CSC)   SharePoint  (Microsoh)   GLS  (Glemser)   PUBLISHING  SYSTEMS         Insight  Publisher  (Liquent)   eCTDXpress  (CSC)   Extedo   GlobalSubmit  Publish   DocuBridge  (Lorenz)   REGISTRATION  TRACKING  SYSTEMS         Insight  Manager  (Liquent)   TRS  Tracker  (CSC)   Trackwise  (Sparta  Systems)   ArisGlobal   DrugTrack  (Lorenz)   Vendor Neutral Product Selection System Implementation, Maintenance and Upgrades User Requirement Specifications (URS), Standards, Process and Training
  20. 20. 9/24/16   20   PRACTICE  AREAS   CONSULTING   R&D  CONSULTING  SERVICES   Business  Strategy   and  Planning   Organiza*onal   Transforma*on   Acquisi*ons  &  Post-­‐ Merger  Integra*on   Process  Excellence   Coaching     e-­‐Communica*ons   and  e-­‐Learning  
  21. 21. 9/24/16   21   CONSULTING  SERVICES   Business  Strategy   and  Planning   Pyxa’s  focus  and  flexibility  provides  the  founda*onal  business   planning  services  essen*al  for  func*onal  or  enterprise-­‐wide   “commitment  and  alignment”  to  the  same  vision,  goals,   *melines  and  objec*ves   Pyxa’s  approach  spurs  collabora*on  and  brainstorming  across   func*ons,  and  across  organiza*ons,  encouraging  stakeholders   to  think  beyond  the  “status  quo”  and  put  equal  emphasis  on   short  term,  as  well  as,  long  term  goals  /  roadmap   Pyxa’s  broad  range  of  flexible  strategic  services  aid  clients  in   defining,  op*mizing  or  refining  their  func*onal  strategic  plans   accoun*ng  for  market-­‐driven  pressures,  such  as  globaliza*on       Cross-­‐Func*onal  R&D  Delivery  
  22. 22. 9/24/16   22   All  organiza*on  transforma*on  deliverables  are  designed  in   alignment  with  the  func*onal  and  enterprise  wide  strategic   objec*ves  to  achieve  measurable  improvements  in  cost,   quality  and  *me-­‐to-­‐market     Pyxa  provides  systema*c  assessment  of  the  organiza*on,   detailed  modeling  (if  needed),  and  detailed   recommenda*ons  based  on  solid  analysis  and  future   projec*ons   Pyxa’s  business  transforma*on  ini*a*ves  include  developing   business  cases,  governance  models,  organiza*onal  surveys   and  assessments,  business  modeling,  skills  and  gaps   assessments  and  func*onal  org  design   CONSULTING  SERVICES   Strategic  &  Cost  Effec*ve  Organiza*ons   Organiza*onal   Transforma*on  
  23. 23. 9/24/16   23   Pyxa  is  sensi*ve  to  internal  poli*cs  and  mo*va*on,  and   works  collabora*vely  across  all  func*ons  of  the  organiza*on,   from  Program  Management,  HR,  R&D,  Commercial,  IT  and   any  others  involved  in  the  integra*on  effort   Pyxa  manages  all  aspects  of  the  integra*on,  including  but  not   limited  to,  the  PMO  office  and  Change  Management   effec*vely  integra*ng  People,  Process  and  Technology     Pyxa  offers  end-­‐to-­‐end  program  management  for  acquisi*ons   and  post-­‐merger  integra*on  support   Integra*ng  People,  Process  and  Technology   CONSULTING  SERVICES   Acquisi*ons  &  Post-­‐ Merger  Integra*on  
  24. 24. 9/24/16   24   We  develop  change  management,  communica*on,  training   (class  room  or  e-­‐learning)  and  implementa*on  plans  and   materials  to  support  the  successful  rollout  of  the  process   We  assess  the  “As-­‐Is”  state  in  a  quick  and  efficient  manner,   iden*fying  areas  of  weakness,  risks  and  gaps.  We  work  cross-­‐ func*onally  to  develop  the  “To-­‐Be”  state,  ensuring  alignment   and  endorsement  across  the  respec*ve  func*ons   Pyxa  offers  a  streamlined  and  holis*c  approach  to  cross-­‐ func*onal  R&D  process  development  and  op*miza*on,  to   enhance  opera*ons  and  ensure  compliance   Effec*ve  and  Efficient  Opera*ons   CONSULTING  SERVICES   Process  Excellence  
  25. 25. 9/24/16   25   We  can  tailor  the  use  of  anima*on,  interac*vity,  audio,  and   video  to  suit  your  par*cular  learning    or  communica*on   needs   Through  our  exper*se  in  R&D  and  Ar*culate  Storyline,  we   can  create  new  eLearning  content  or  re-­‐purpose  your  exis*ng   content.  The  content  can  be  run  through  our  Learning   Management  System  (LMS),  or  through  any  3rd  party  LMS     Pyxa  specializes  in  developing  cost-­‐effec*ve,  yet  highly   engaging,  custom  content  and  online  courseware  and   communica*ons     Unified  Messaging  for  Streamlined  Opera*ons     CONSULTING  SERVICES   e-­‐Communica*ons   and  e-­‐Learning  
  26. 26. 9/24/16   26   Coaching     CONSULTING  SERVICES   Pyxa  offers  a  blend  of  coaching  services  to  aid  organiza*ons   in  developing,  enhancing  and  progressing  internal  strategic   capabili*es  for  cross-­‐func*onal  collabora*ons,  advancement   in  leadership  abili*es,  streamlining  opera*ons  and  more.       These  services  vary  from  1:1  support  to  group   workshops  and  seminars.     Business  Process  Excellence   Change  Management     Leadership   Training  
  27. 27. 9/24/16   27   PRACTICE  AREAS    R&D  TECHNOLOGY   SERVICES   TECHNOLOGY   Business  Case   Strategic  Planning   Opera*onal   Excellence  
  28. 28. 9/24/16   28   TECHNOLOGY  SERVICES   BUSINESS  CASE   IT  system  jus*fica*on  for  new  or   replacement  systems  (ROI)     System  assessment  vs.  func*onal  and/or   regulatory  requirements   NEW  SYSTEM  DESIGN   AND  BUILD   CUSTOM  VS.  OFF-­‐THE-­‐SHELF   SOLUTIONS   JUSTIFICATION AND VALUE PROPOSITION FOR TECHNOLOGY NEEDS
  29. 29. 9/24/16   29   TECHNOLOGY  SERVICES   STRATEGIC  PLANNING   Pyxa  partners  with  clients  to  develop  sustainable   strategies,  technology  roadmaps  and  systems  for  the   management  of  regulatory-­‐focused  content  throughout   the  product  lifecycle.   We  bring  deep  exper*se  in  business  strategy,   opera*onal  transforma*on  and  technology  to  deliver   solu*ons  that  creates  measurable  business  value  and   jus*fies  technology  spend.   STRATEGIC INNOVATIVE R&D SOLUTIONS DEVELOPMENT AND IMPLEMENTATION INNOVATING  TECHNOLOGIES   AND  BEING  EARLIER  ADOPTERS     LEADING  ADVANCEMENTS   WITHIN  THE  INDUSTRY   MOBILE  INTEGRATION  STRATEGY  AND  DESIGN  
  30. 30. 9/24/16   30   TECHNOLOGY  SERVICES   OPERATIONAL  EXCELLENCE   Cross-­‐func*onal  data  governance,  analysis  &  mapping     Source  system  integra*on  and  roadmap     Enterprise  architecture  and  governance     Opera*on  IT  plan  development     Implementa*on  plans     Informa*on  architecture  /  requirements  assessment       CONNECTING  INFORMATION   FLOWS  AND  DATA     KEEPING  PROCESSES  AND   SYSTEMS  SIMPLE   IMPLEMENTATION AND OPERATIONAL PLANNING FOR LONG TERM SUCCESS
  31. 31. 9/24/16   31   WHY  PYXA?   COLLABORATE  &  LISTEN   PROBLEM  SOLVE  &  PLAN   FLEXIBLE   INNOVATE   Pyxa  is  managed  by  a  blended  team  of   industry  experts  and  management   consultants   We  listen  to  our  clients  needs  and   collaborate  to  ensure  alignment   throughout  the  engagement   We  solve  complex  problems  with   ac*onable  plans.  We  deliver  QUALITY   projects  ON  TIME  and  ON  BUDGET   Our  flexible  approach  and  experience  in     iden*fying  and  implemen*ng  solu*ons  allows   us  to  respond  to  a  client’s  changing  needs   INDUSTRY  EXPERTS   We  innovate  and  provide  a  framework  for   integra*ng  and  bridging  knowledge  across   mul*ple  technologies  and  thought  leaders  
  32. 32. Contact  US   INFO@PYXASOLUTIONS.COM    

×