#actd

[cazluvsu]

jalen brunson is a single mom who works two jobs who loves her kids and never stops

[goldenguillotines]

[king-of-havoc]

Aw motherfucker... worst thing about being high is making and eating food and FORGETTING YOU ATE IT AND YOU WANNA EAT IT AGAIN CUZ IT SOUND SO YUMMY RN

but I also have a......... uh.............. wassit............ apple pie but not.......... FITTER APPLE FRITTER i have a apple fritter -w-

[msc137]

Youre basically forcing them to play drug trip supervisor without them knowing??

they dont gave to zusperbize im fuckigngs fine

guck this dhit actd fady holy cral this is a milkikn timsz betterc ghan drinniinh

[x-0h-m3-0h-my]

🛠Is there a scene or anything in the WIP you are struggling with right now?

yes! im struggling so hard with the scene in ACTD where grant cohen is finally introduced. im struggling with pacing and just sheerly how many people are in the group at this point in the story (which isnt resolved until much later)

[sudheervanguri]

Skycare Pharmaceuticals is hiring Regulatory Affairs Executives to join their growing team. If you have a B.Pharm or M.Pharm degree and 1-3 years of relevant experience, this could be the perfect role for you. Job Overview Position: Regulatory Affairs Executive Location: Ahmedabad, Gujarat Qualifications: B.Pharm, M.Pharm Experience: 1-3 years in regulatory affairs As a Regulatory Affairs Executive, you will play a key role in dossier filing and ensuring the company’s products comply with global pharmaceutical regulations. You will work closely with internal teams and external stakeholders, helping guide the company through the regulatory landscape. Key Responsibilities dossier filing Develop and implement regulatory strategies to ensure compliance with local and Minimum knowledge of CTD, ACTD,ECTD filing and in depth knowledge of international regulations and guidelines for pharmaceutical products. Preparation and submission of dossiers, including drug applications, variations, renewals etc. Stay updated on changes in regulatory requirements and communicate these changes to relevant stakeholders within the company. Coordinate with cross-functional teams, including R&D, quality assurance, and marketing, to ensure regulatory compliance throughout the product lifecycle. Develop and maintain relationships with key stakeholders Provide regulatory input for product development, including reviewing and approving labeling, packaging, and promotional materials. [caption id="attachment_106707" align="aligncenter" width="930"] Skycare PharmaceuticalsRecruitment - Job vacancies[/caption] Required Skills and Qualifications Degree: B.Pharm or M.Pharm is mandatory for this role. Experience: 1-3 years of hands-on experience in regulatory affairs, with specific experience in dossier preparation and submission. Knowledge: Familiarity with CTD, ACTD, eCTD guidelines, and a deep understanding of international pharmaceutical regulations. Skills: Strong organizational skills, attention to detail, and the ability to work with cross-functional teams. How to Apply If you are a qualified candidate with experience in regulatory affairs, Skycare Pharmaceuticals wants to hear from you! To apply, send your resume to info@skycarepharma.com or reach out via WhatsApp at +91 98750 11522.

[ihspl]

Indivirtus Healthcare Services

As a Contract Research Organization (CRO), Indivirtus Healthcare Services offers a wide range of services within the pharmaceutical and healthcare sectors. Initially, the company specialized in delivering Toxicological Risk Assessment Reports to pharmaceutical manufacturers. However, over time, it has expanded its service offerings to include numerous other services.

Established in 2018, Indivirtus Healthcare Services began its journey in a modest single-room office, staffed by just two individuals, led by Dr. Upendra Jain and Ms. Veena Kumari. Over the span of six years, this humble organization has evolved into a group of five companies, boasting seven offices worldwide and a workforce of over 100 employees. Indivirtus Healthcare Services has successfully served more than 500 clients across over 45 countries.

The range of services provided by Indivirtus Healthcare Services includes:

Toxicology:

Toxicology is the scientific field that involves the study of the harmful effects of chemicals on living organisms.

Cleaning Validation: This service ensures cleanliness to prevent contamination during production processes. It is achieved by calculating MACO (maximum allowable carryover) values based on health-based exposure limits such as PDE (Permitted Daily Exposure), ADE (Allowed Daily Exposure), and OEL (Occupational Exposure Limit), all established through thorough risk assessments. These reports adhere to guidelines set by EMA, ICH, APIC, AND PICS.

Genotoxic Evaluations of Impurities: Utilizing ICH M7 guidelines, this service assesses the genotoxicity and mutagenicity of impurities to determine their acceptability in drug substances and products.

Material Safety Data Sheets (MSDS): These provide detailed information on the safety and handling of materials.

GRAS Reports: These confirm the safety of substances for their intended use.

Regulatory Affairs/Regulatory Affairs (RA/Reg Affairs)

Preparation and Submission of CTD, ACTD & e-CTD Dossiers

Dossiers for Regulated, Semi-regulated, and WHO Regulated Market

CEP Filing & Submission on the EDQM Portal and DMF Filing to the FDA

Clinical & Non-Clinical Overviews and Summaries

Batch Releasing & Testing Site Service for Europe (BRS & BTS)

MAH & Local Agent Service for Europe & US

Pharmacovigilance and Drug Safety Services

PSMF Management

Single Case and Adverse Event Reporting

Aggregate Report Generation

Safety Physicians Support

Signal Management & Safety Surveillance

Literature Monitoring (Global and Local)

Medical Writing

Risk Management Plans (RMPs)

Electronic Submission Management

Medical Information Call Centre (MICC)

Qualified Person for Pharmacovigilance (QPPV) Support

Regulatory Authority Requests and Audit/Inspection Readiness

Social Media Monitoring for Adverse Events

Calibration Services

Indivirtus Healthcare Services is equipped to provide a variety of calibration services through a facility accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories) (ISO/IEC: 17025:2017). Our calibration services cover a broad spectrum, including:

Calibration Facility in various dimensions, pressure, mass, volume, RPM, sound, electro-technical, and thermal.

Temperature Mapping and Validation Facility for Furnace, Chambers, Oven, and Cold Storage.

On-site Facility for Calibration.

Training on Quality Systems & Implementation.

Computerized System Validation (CSV)

Indivirtus Healthcare Services is dedicated to providing comprehensive services in CSV to ensure that systems are performing their intended tasks effectively. Our CSV services include:

Implementation and Validation of Computerized Systems.

Decommissioning of Computerized Systems.

Cloud Systems Validation.

Quality Systems for IT Departments and IT Service Suppliers.

Quality Systems for Software Validation.

Computer Infrastructure Qualification.

Audits for IT Solution Suppliers.

Training.

Clinical Research & Equivalence Studies

Indivirtus Healthcare Services provides a range of clinical research services, including feasibility assessments, participation in regulatory discussions, project oversight, management of clinical sites, handling of data and statistical analysis, and the conduct of Phase I, II, III clinical studies.

Technology Transfer (Tech Transfer)

Indivirtus Healthcare Services specializes in technology transfer services, facilitating the transition of drug substance production processes from research laboratories to commercial facilities. Our services include CMO (Commercial Manufacturing) site transfers and CMDO (Research and Development to Commercialization) services. We handle various aspects of technology transfer, such as:

Site transfers

Research and Development/Funding and Development

Dossiers/Know-how

Good Manufacturing Practices (GxP) and Auditing Services

Indivirtus Healthcare Services offers a variety of audit services to help identify and address deficiencies in processes, ensuring compliance. Our audit services include:

Internal audits and Good, Environment, Management, and Business Analysis (GEMBA) sessions

Third-party audits and Gap assessments

Pre-inspection and Due Diligence audits

Additional Services Provided by Indivirtus Healthcare Services include:

CMO/CDMO Facilities for the Sourcing of Formulations and Active Pharmaceutical Ingredients (APIs)

Greenfield/Brownfield Development Projects

[love-strikes-thrice]

YOU CAN'T JUST LEAVE THAT LAST BIT IN THE TAGS-

***

Miles: so I started seeing this guy~

Peter B., torn between being supportive and being a shithead: Good for you, kid, you were single for so long even I was getting depressed

Miles: >:(

Peter B.: I'm just kidding! C'mon, tell me about him!

Miles: Okay, so his name is Mikey, and he's the same age as me but he's homeschooled so we don't go to the same school which kind of sucks because I don't get to see him as much as I'd like to

Peter B.: Okay

Miles: But he's super into graffiti art like me - that's how we met, by the way - so we hang out after I get out of class and on weekends and stuff when we're not patrolling

Peter B.: I'm sorry, when "we're" not patrolling? What, do you bring your boyfriend with you on patrol?

Miles: oh, yeah! He's a vigilante too - well, he's a ninja, technically, but he actd more like a vigilante than a traditional ninja anyway

Peter B.: . . . A ninja?

Miles: Yeah! It's actually super cool, he and his brothers are all ninjas! It's awesome!

Peter B.: . . . How many brothers does he have?

Miles: He's got three older brothers, I think their names are Raphael, Donatello, and Leonardo? They use a bunch of different nicknames a lot so I'm not totally sure but I think that's their names.

Peter B.: Miles, answer me honestly

Miles: . . . Ooooookay?

Peter B.: Are you dating Michelangelo from the Teenage Mutant Ninja Turtles?

Miles: how did you know they were mutant turtles?

Peter B.: Holy Fucking Shit, you're dating Michelangelo from the Teenage Mutant Ninja Turtles

Miles: What is happening? Why are you being weird?

Peter B.: Why are you dating a cartoon character from my childhood? Huh?

Miles: What????

Boyfriend problems.

Leo: RaphRaphRaphRaph I have amazing news! I got a boyfriend.

Raph: Aw that's awesome! Who is he?

Leo: Yuichi Usagi, remember that rabbit waiter?

Raph, who is scared of rabbits:..The what waiter?

--

Mikey: Dad. I started dating this guy.

Splinter: That's good, tell me what is he like?

Mikey: He is so COOL! He has spider powers–

Splinter: He has what powers?

[skeetlebeetle]

oh god oh fuck accidentally began a txt conversation w sum1 i havnt talkd 2 in monthz on acc of them moving away n also they were kind of a dirty backstabbing bitch but i actd liek we were all kool afterwardz even tho i’d rathr not resume friendship w em aaaa get me oooout

[the-firebird69]

he has always been the guy just has a beard. and i fight him all the tiime, is my enemy and i did the shop wiht him there. odd as hell. he is a winner huh. lol

dutchess meghan

and i knew her from westboro mywife snuck in but she was amy. looked like this image. different person lol. actd different and anatomically allsay nope different. and was normal did normal stuff. weas a bit of a thief, got out of it. and was a decent person to talk to like a teenage boy lol. was a tom boy but later big hair and a sluttish. but cool ok. down to earth. and said it too dont want more i am too drunk...nope. and need to study you out. and a lot of times. it was realistic life stuff and others had wierdness

Zues Hera

true too i was like that and right on hte money and needed help today and he said it the clones are here tons. and they saw it. are hienous. we sent out hi sinfor said it they have us fight. and are in our mdst and they stop them now

meghan

and you all die and thetypist

tommy f

your out tommyf. will have you hit now ok bud. bye bye fag tom

Zues Hera of course i can have it

you and your ship need a posessed capt ok lol

fine is ee. in me already and i ck cnt see it and not a computer wiz and oh boy fine

tommy f

[mcarepharmaexportsfromindia]

How to Import Medicine From India

Is it true that you are a drug merchant who needs to import great Indian medications? In the event that indeed, it is a lot of fundamental for you to know the standards and guidelines relevant in India as well as your particular country.

Each nation has separate import standards for drugs or any products so far as that is concerned. Consequently, gathering required data from various sources is in every case great.

You can look for sites on the Web for that…Read More

FDA Approval and requirements

Indian drug organizations should get endorsement for sending out the meds to a particular country. There are independent consents for every country.

Consequently, you should make sure that the organization you are bringing in medications has the fundamental endorsement in India to send out prescriptions in your country.

Because of any resistance of the pharma organization, you shouldn’t cause problems.

For instance, to trade prescriptions in Bedouin nations, the pharma organization requires GCC endorsement and the endorsement from Saudi FDA.

To trade in Lebanon or Syria; endorsement from the US FDA, EU GMP or Japanese FDA is required. To send in Bhutan, Myanmar or Vietnam, you really want ACTD Dossier and item enlistment.

Accordingly, you should realize the data prior to marking the import contract.

Other requirements

According to the Import/Commodity guidelines in India, an organization needs to get the exporter’s code number from the Save Bank of India.

Likewise, it is required to get the IEC code without that it is preposterous to expect to send prescriptions out of India. The IEC number is expected to open a ledger that is approved to bargain in unfamiliar trade.

On the off chance that you are bringing in medications from India, make sure that the pharma organization gives you the product code number and IEC code.

There are standards about giving the letter of credit and In-process quality control. These perspectives ought to be known to you in advance.

It is exceptionally easy to import meds from India assuming that you get a comprehension of the guidelines. The most ideal way is to recruit a specialist.

Top-quality medicines make India a preferred import partner

India has arisen as one of the assembling nations where merchants get the best drugs and straightforward strategies.

With the lift in the Indian economy, increasingly more pharma organizations are arising into the commodity import market for medication

M Care being the global supplier of Pharmaceutical formulation, API, KSN & intermediate products and a member of Pharmexcil are ready to provide international exposure to manufacturers for registration of their products and sales and academia for research and development. We also assist clinical research.We are exporting medicines from India to different countries like United Arab Emirates, United States, Brazil, Saudi Arabia, etc. for More Information click here…

[9kmovies-biz]

Regulatory affairs executive Jobs

Job Description Hello Connections, Greetings We are hiring for ” Regulatory affairs executive “ Skills : cosmetic licensing and labelling. REACH regulation(must). Dossiers preparation ECTD, /ACTD Experience: 1to 4 Years Location: #Bangalore Work Type: Work from office Job Type: Permanent #Regulatory #affairs #executive #Jobs

[hmapernata]

,,,,,

uuuhhhhuh,,,

okauy so um,,,,, went2 fanficulfoundation,,,,, met a hmapr. they acted weirdb,,, said they wer mandi but somethig was of f,,,,,, they actd like,,,, like they qwere reciting a scrip t,,,,,

took me 2basement,,,, tried to grab me. i jumpd away n they fell down,,, startd cryingb,,, said they dont kno,,,they confus. only know how2 obey,,,,

and itold them they didntn have to b alone,,, and we left

@hmapernata

m,,, mam,a,,?

Hi....

What's up, baby?

[sudheervanguri]

Albios Lifesciences Hiring Experienced Regulatory Officers for Ahmedabad Location Albios Lifesciences Pvt. Ltd. is actively seeking Experienced Regulatory Officers to join their Regulatory Affairs (RA) department in Ahmedabad. If you have a solid background in regulatory processes and dossier preparation, this could be the perfect role for you. With a focus on Southeast Asian guidelines and FDA-related work, this is a great opportunity to grow in a leading pharmaceutical company. Job Overview Position: Senior Regulatory Officer Location: Makarba, Off S G Highway, Ahmedabad, Gujarat Experience: 2-5 years in Regulatory Affairs Salary: Rs. 03.00 LPA to Rs. 03.60 LPA Job Type: Full-time, 6 days a week Working Hours: 9:00 AM to 5:30 PM Albios Lifesciences, a leading player in the pharmaceutical sector, is hiring for its RA Department. The role requires experienced professionals who are well-versed in dossier preparation, FDA compliance, and coordination with manufacturers regarding quality documents. The company offers a competitive salary package and a chance to work in a dynamic, growing organization. Key Responsibilities As an Experienced Regulatory Officer at Albios Lifesciences, you will be responsible for: Preparation of CTD and ACTD Dossiers. Should have knowledge about Southeast Asian guidelines for Dossier preparation. Preparation and Reviewing Artwork Coordination with manufacturers regarding quality documents. Reviewing quality documents Should have sound knowledge of FDA related work. (Product Permission, COPP, Mfg.   License, GMP certificate). Prepare and submit query response within timeline. This role requires attention to detail and strong communication skills, as you will be the bridge between Albios Lifesciences and regulatory authorities. Qualifications and Requirements To qualify for the Senior Regulatory Officer role, you should have: Education: A Bachelor's or Master’s degree in Life Sciences, Pharmacy, or a related field. Experience: 2-5 years of hands-on experience in regulatory affairs, particularly in dossier preparation, FDA compliance, and coordination with manufacturing teams. Skills: Proficiency in Microsoft Office (Word, Excel, PowerPoint). Excellent English communication skills (verbal and written). Knowledge of Southeast Asian guidelines and FDA regulations is mandatory. Strong organizational and time management skills. [caption id="attachment_104562" align="aligncenter" width="930"] Albios India pvt ltd Recruitment - Job vacancies[/caption] Perks: Competitive salary ranging from Rs. 03.00 to 03.60 LPA. Opportunity to work in the rapidly growing pharmaceutical hub of Ahmedabad. A chance to build your career with a company that values professional growth and quality. How to Apply If you meet the qualifications and are interested in advancing your career with Albios Lifesciences, we encourage you to apply today. Send your updated resume to hr.albioslifesciences@gmail.com or contact +91-9512006684 for more information.

[ace-m0rningstar]

I have a huge amount for backlogged art from this project so I'm going to try and periodically post it over the next few days. This is just a basic character reference of the protagonist Alex. #art #digitalart #graphicartwork #graphicart #firealpaca #oc #character #protagonist #fantasy #redhair #refrence #refsheet #actd #acalltodarkness https://www.instagram.com/p/CLhaq88HBCi/?igshid=1e2actp3146xg

[faerociousbeast]

aoi (the purple one. the girl from tbhk) is a lesbian